Bipolar Disorder, Schizo Affective Disorder
Conditions
Keywords
Brain Stimulation, Mania
Brief summary
Mania is a core symptom of bipolar disorder involving periods of euphoria. Decreased inhibitory control, increased risk-taking behaviors, and aberrant reward processing are some of the more recognized symptoms of bipolar disorder and are included in the diagnostic criteria for mania. Current drug therapies for mania are frequently intolerable, ineffective, and carry significant risk for side effects. Presently there are no neurobiologically informed therapies that treat or prevent mania. However, using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions having a causal role in the development of mania in people without a psychiatric history can occur in different brain locations, such as the right orbitofrontal cortex (OFC), right dorsolateral prefrontal cortex (DLPFC), and right inferior temporal gyrus (ITG). This lesion network evidence converges with existing cross-sectional and longitudinal observations in bipolar mania that have identified specific disruptions in network communication between the amygdala and ventro-lateral prefrontal cortex. The OFC is associated with inhibitory control, risk-taking behavior, and reward learning which are major components of bipolar mania. Thus, the association between OFC with mania symptoms, inhibitory control, risk-taking behavior, and reward processing suggests that this region could be targeted using non-invasive brain stimulation.
Detailed description
Mania is a core symptom of bipolar disorder involving periods of euphoria, delusions, and overactivity. Mania occurs in multiple medical and psychiatric illnesses and can be refractory to existing treatments. Two recent studies using brain lesion mapping of psychiatrically healthy individuals presenting with mania identified causal locations in the brain, including the orbitofrontal cortex (OFC), dorsolateral prefrontal cortex (DLPFC), and inferior temporal gyrus (ITG), that were associated with new onset mania symptoms. Moreover, these identified brain regions have also been implicated in bipolar mania with specific disruption in network communication between the amygdala and ventro-lateral prefrontal cortex. The OFC is of particular interest because it is a brain structure that is associated with inhibitory control, risk-taking behavior and reward, which are major behavioral components of mania. Thus, the association between OFC with mania symptoms, inhibitory control, risk-taking behavior and reward suggests that this region could be targeted using noninvasive brain stimulation. While several studies have non-invasively targeted the DLPFC for mania, no study to date has non-invasively stimulated the OFC with either transcranial direct current stimulation (tDCS) or alternating current (tACS) in bipolar disorder and examined its effects on mania, inhibitory control, or risk-taking behavior. However, a study in healthy volunteers showed that cathodal stimulation to the OFC enhanced inhibitory control and decreased risk-taking behavior. Recently, researches have showed that targeting the OFC with tACS, personalized to the individual's intrinsic beta-gamma frequency of the reward network, that individuals showed rapid, reversible, frequency-specific modulation of reward-guided choice behavior and learning. Here we aim to answer the question of whether noninvasive brain stimulation when optimally targeted and personalized to an individual's beta-gamma frequency to the OFC can improve emotional cognitive processing and mania symptoms compared to tDCS or sham targeting. The knowledge gained from this study will provide a marker for clinical response and allow personalized treatment for patients with bipolar disorder.
Interventions
DEVICEHigh-Definition Transcranial Electrical-Current Stimulation
Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
DEVICEHigh-Definition Transcranial Alternate-Current Stimulation
Active-control stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment
DEVICEHigh-Definition Personalized Beta-Gamma Electrical Stimulation
Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-65 years of age 2. Proficient in English 3. Able to give informed consent 4. Meet diagnostic criteria for bipolar disorder or schizoaffective disorder, bipolar type as verified by the SCID 5. History of mania ( \>1 lifetime episode) 6. Experiencing mild to moderate symptoms of mania 7. No changes to mood stabilizing medications for a period of 2 weeks prior to participation 8. Has not recently participated in tES/TMS treatments
Exclusion criteria
1. Substance abuse or dependence (w/in past 6 months) 2. Those who are pregnant/breastfeeding 3. History of head injury with \> 15 minutes of loss of consciousness/mal sequelae 4. DSM-V intellectual disability 5. Having a non-removable ferromagnetic metal within the body (particularly in the head) 6. History of seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Young Mania Rating Scale (YMRS) | Change from baseline to 5 Day follow-up | Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms |
| Altman Self-Rating Mania Scale (ASRM) | Change from baseline to 5 Day follow-up | The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition. |
| Psychiatric Hospitalizations for Mania Post Study Entry | Cumulative count of hospitalizations for mania from baseline to end of study | Psychiatric hospitalization for mania. Count of hospitalizations from baseline to end of study period assessed at Day 5, 1 Month & 3 Month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reinforcement Learning Task | Change from baseline to 5 Day follow-up | The reinforcement learning task is a monetary based learning tasks that included reward and punishment trails. The task presents multiple trials of stimuli where the participant chooses 1 of 2 stimuli presented at a time (one of which is associated with punishment represented by loss of monetary reward while the other is associated with gain of monetary reward). EEG is record during the task and signal is captured during the participants choose and the feedback received. Reported is the peak beta/gamma range response derived from the EEG during reward feedback. This measurement is used from the baseline assessment to inform the personalized beta-gamma range stimulation for the Personalized Beta-Gamma tACS group. |
| Social Functioning Scale (SFS) | Change from baseline to 5 Day follow-up | The SFS a self-report questionnaire initially designed for people diagnosed with Schizophrenia; consists of 79 items designed to reflect the social skills and performances in different areas of life. Subscores are summed together for a total score. Total score of SFS ranges between 0-223 points. Higher scores mean better social functioning. |
| Global Assessment of Functioning (GAF) | Change from baseline to 5 Day follow-up | The GAF measures how symptoms affect individuals day-to-day life; scored from 0 to 100 |
| Balloon Analogue Risk Task (BART) | Change from baseline to 5 Day follow-up | The BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial. |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | Change from baseline to 5 Day follow-up | The MADRS is designed to measure depression and severity of symptoms; 0 to 6 indicates no depression, 7 to 19 indicates mild depression, 20 to 34 indicates moderate depression, 35 and greater indicates severe depression. Total score reported (0 to 60). |
| Barratt Impulsiveness Scale-11 (BIS-11) | Change from baseline to 5 Day follow-up | The BIS-11 is designed to assess the personality/behavioral impulsiveness. The BIS-11 has 30 items and is scored appropriately. Scored to yield a total score, three second-order factors, and six first-order factors. Each question has a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Higher scores mean more impulsive behavior. Total score reported (30-120). |
| Brief Assessment of Cognition (BACS) | Change from baseline to 5 Day follow-up | The BACS is designed to assess several domains of cognition; Verbal Memory; Processing Speed; Working Memory; Verbal Fluency; Motor Function; Executive Functioning. Higher scores indicate better cognitive functioning. Total score reported after being transformed into z score based on normative scoring provide by test makers. |
| Positive and Negative Syndrome Scale (PANSS) | Change from baseline to 5 Day follow-up | 30 items included in the PANSS measuring positive, negative and general symptoms; 7 related to positive symptoms, 7 for negative symptoms, and 16 for general psychopathology Scale. Ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Scores summed for Total Score on scale (30 to 210). Higher scores mean worse clinical symptoms. Total score reported. |
| The Go/No Go Task | Change from baseline to 5 Day follow-up | The Go/No Go Task is a computerized task that measures impulsiveness. Participants presented with Go (to respond) and no Go (when not to respond) instructions. Two trials are performed. The first trial consist of two distinct auditory stimuli (both Go stimuli) where the participant is asked to respond with a different number of mouse clicks to the stimuli respectively. The second trial, has a no Go stimuli (where the participant is suppose to withhold a response) and a go stimuli. Reaction time for correct trials only for the entire task are reported in milliseconds. |
| Electroencephalography (EEG) Resting State | Change from baseline to 5 Day follow-up | Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma. |
Countries
United States
Participant flow
Pre-assignment details
Individuals were randomized into 1 of 3 protocol arms (tDCS, 10hz tACS or personalized tACS)
Participants by arm
| Arm | Count |
|---|---|
| HD-tDCS HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment | 5 |
| HD-tACS (Alpha, 10 Hz) 10 Hz HD-tACS; Two, twenty-minute sessions of passive sham control to the OFC for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: Active-control stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment | 4 |
| Personalized Beta-Gamma HD-tACS Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment | 5 |
| Total | 14 |
Baseline characteristics
| Characteristic | Total | HD-tDCS | HD-tACS (Alpha, 10 Hz) | Personalized Beta-Gamma HD-tACS |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 5 Participants | 4 Participants | 5 Participants |
| Age, Continuous | 34.29 years STANDARD_DEVIATION 11.07 | 35.2 years STANDARD_DEVIATION 10.402 | 38.25 years STANDARD_DEVIATION 12.685 | 30.2 years STANDARD_DEVIATION 11.476 |
| Altman Self-Rating Mania Scale (ASRM) | 5 score on a scale | 5 score on a scale | 7 score on a scale | 3 score on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 5 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 14 participants | 5 participants | 4 participants | 5 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 1 / 5 | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 5 |
Outcome results
Primary
Altman Self-Rating Mania Scale (ASRM)
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Altman Self-Rating Mania Scale (ASRM) | Baseline | 5 score on a scale |
| HD-tDCS | Altman Self-Rating Mania Scale (ASRM) | 1 Month | 2 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Altman Self-Rating Mania Scale (ASRM) | Baseline | 7 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Altman Self-Rating Mania Scale (ASRM) | 1 Month | 4 score on a scale |
| Personalized Beta-Gamma tACS | Altman Self-Rating Mania Scale (ASRM) | Baseline | 3 score on a scale |
| Personalized Beta-Gamma tACS | Altman Self-Rating Mania Scale (ASRM) | 1 Month | 5 score on a scale |
Primary
Altman Self-Rating Mania Scale (ASRM)
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Altman Self-Rating Mania Scale (ASRM) | Baseline | 5 score on a scale |
| HD-tDCS | Altman Self-Rating Mania Scale (ASRM) | 3 Month | 2 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Altman Self-Rating Mania Scale (ASRM) | Baseline | 7 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Altman Self-Rating Mania Scale (ASRM) | 3 Month | 3.6 score on a scale |
| Personalized Beta-Gamma tACS | Altman Self-Rating Mania Scale (ASRM) | Baseline | 3 score on a scale |
| Personalized Beta-Gamma tACS | Altman Self-Rating Mania Scale (ASRM) | 3 Month | 6 score on a scale |
Primary
Altman Self-Rating Mania Scale (ASRM)
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Time frame: Change from baseline to 5 Day follow-up
Population: Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Altman Self-Rating Mania Scale (ASRM) | Baseline | 5 score on a scale |
| HD-tDCS | Altman Self-Rating Mania Scale (ASRM) | Day 5 | 7 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Altman Self-Rating Mania Scale (ASRM) | Baseline | 7 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Altman Self-Rating Mania Scale (ASRM) | Day 5 | 2 score on a scale |
| Personalized Beta-Gamma tACS | Altman Self-Rating Mania Scale (ASRM) | Baseline | 3 score on a scale |
| Personalized Beta-Gamma tACS | Altman Self-Rating Mania Scale (ASRM) | Day 5 | 5 score on a scale |
Primary
Psychiatric Hospitalizations for Mania Post Study Entry
Psychiatric hospitalization for mania. Count of hospitalizations from baseline to end of study period assessed at Day 5, 1 Month & 3 Month.
Time frame: Cumulative count of hospitalizations for mania from baseline to end of study
Population: Cumulative count of hospitalizations for mania from baseline to end of study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HD-tDCS | Psychiatric Hospitalizations for Mania Post Study Entry | Baseline | 0 number of hospitalizations |
| HD-tDCS | Psychiatric Hospitalizations for Mania Post Study Entry | Day 5 | 0 number of hospitalizations |
| HD-tDCS | Psychiatric Hospitalizations for Mania Post Study Entry | 1 Month | 0 number of hospitalizations |
| HD-tDCS | Psychiatric Hospitalizations for Mania Post Study Entry | 3 Month | 0 number of hospitalizations |
| HD-tACS (Alpha, 10 Hz) | Psychiatric Hospitalizations for Mania Post Study Entry | 3 Month | 0 number of hospitalizations |
| HD-tACS (Alpha, 10 Hz) | Psychiatric Hospitalizations for Mania Post Study Entry | Baseline | 0 number of hospitalizations |
| HD-tACS (Alpha, 10 Hz) | Psychiatric Hospitalizations for Mania Post Study Entry | 1 Month | 1 number of hospitalizations |
| HD-tACS (Alpha, 10 Hz) | Psychiatric Hospitalizations for Mania Post Study Entry | Day 5 | 0 number of hospitalizations |
| Personalized Beta-Gamma tACS | Psychiatric Hospitalizations for Mania Post Study Entry | 3 Month | 0 number of hospitalizations |
| Personalized Beta-Gamma tACS | Psychiatric Hospitalizations for Mania Post Study Entry | Day 5 | 0 number of hospitalizations |
| Personalized Beta-Gamma tACS | Psychiatric Hospitalizations for Mania Post Study Entry | 1 Month | 0 number of hospitalizations |
| Personalized Beta-Gamma tACS | Psychiatric Hospitalizations for Mania Post Study Entry | Baseline | 0 number of hospitalizations |
Primary
Young Mania Rating Scale (YMRS)
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Time frame: Change from baseline to 5 Day follow-up
Population: Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Young Mania Rating Scale (YMRS) | Baseline | 5.5 score on a scale |
| HD-tDCS | Young Mania Rating Scale (YMRS) | Day 5 | 3 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Young Mania Rating Scale (YMRS) | Baseline | 11.8 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Young Mania Rating Scale (YMRS) | Day 5 | 8 score on a scale |
| Personalized Beta-Gamma tACS | Young Mania Rating Scale (YMRS) | Baseline | 7.5 score on a scale |
| Personalized Beta-Gamma tACS | Young Mania Rating Scale (YMRS) | Day 5 | 3 score on a scale |
Primary
Young Mania Rating Scale (YMRS)
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice R package used for 1 individual 1 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Young Mania Rating Scale (YMRS) | Baseline | 5.5 score on a scale |
| HD-tDCS | Young Mania Rating Scale (YMRS) | 1 Month | 1.5 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Young Mania Rating Scale (YMRS) | Baseline | 11.8 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Young Mania Rating Scale (YMRS) | 1 Month | 11 score on a scale |
| Personalized Beta-Gamma tACS | Young Mania Rating Scale (YMRS) | Baseline | 7.5 score on a scale |
| Personalized Beta-Gamma tACS | Young Mania Rating Scale (YMRS) | 1 Month | 4 score on a scale |
Primary
Young Mania Rating Scale (YMRS)
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Young Mania Rating Scale (YMRS) | Baseline | 5.5 score on a scale |
| HD-tDCS | Young Mania Rating Scale (YMRS) | 3 Month | 2.6 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Young Mania Rating Scale (YMRS) | Baseline | 11.8 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Young Mania Rating Scale (YMRS) | 3 Month | 7.5 score on a scale |
| Personalized Beta-Gamma tACS | Young Mania Rating Scale (YMRS) | Baseline | 7.5 score on a scale |
| Personalized Beta-Gamma tACS | Young Mania Rating Scale (YMRS) | 3 Month | 2 score on a scale |
Secondary
Balloon Analogue Risk Task (BART)
The BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial.
Time frame: Change from baseline to 5 Day follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Balloon Analogue Risk Task (BART) | Baseline | 16 popped balloons |
| HD-tDCS | Balloon Analogue Risk Task (BART) | Day 5 | 17 popped balloons |
| HD-tACS (Alpha, 10 Hz) | Balloon Analogue Risk Task (BART) | Baseline | 13.5 popped balloons |
| HD-tACS (Alpha, 10 Hz) | Balloon Analogue Risk Task (BART) | Day 5 | 13.5 popped balloons |
| Personalized Beta-Gamma tACS | Balloon Analogue Risk Task (BART) | Baseline | 13 popped balloons |
| Personalized Beta-Gamma tACS | Balloon Analogue Risk Task (BART) | Day 5 | 18 popped balloons |
Secondary
Balloon Analogue Risk Task (BART)
The BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial.
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individual's 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Balloon Analogue Risk Task (BART) | Baseline | 16 popped balloons |
| HD-tDCS | Balloon Analogue Risk Task (BART) | 1 Month | 15 popped balloons |
| HD-tACS (Alpha, 10 Hz) | Balloon Analogue Risk Task (BART) | Baseline | 13.5 popped balloons |
| HD-tACS (Alpha, 10 Hz) | Balloon Analogue Risk Task (BART) | 1 Month | 14.1 popped balloons |
| Personalized Beta-Gamma tACS | Balloon Analogue Risk Task (BART) | Baseline | 13 popped balloons |
| Personalized Beta-Gamma tACS | Balloon Analogue Risk Task (BART) | 1 Month | 27 popped balloons |
Secondary
Balloon Analogue Risk Task (BART)
The BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial.
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R packaged used to impute 5 individuals' 3 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Balloon Analogue Risk Task (BART) | Baseline | 16 popped balloons |
| HD-tDCS | Balloon Analogue Risk Task (BART) | 3 Month | 12.2 popped balloons |
| HD-tACS (Alpha, 10 Hz) | Balloon Analogue Risk Task (BART) | Baseline | 13.5 popped balloons |
| HD-tACS (Alpha, 10 Hz) | Balloon Analogue Risk Task (BART) | 3 Month | 14.7 popped balloons |
| Personalized Beta-Gamma tACS | Balloon Analogue Risk Task (BART) | Baseline | 13 popped balloons |
| Personalized Beta-Gamma tACS | Balloon Analogue Risk Task (BART) | 3 Month | 18 popped balloons |
Secondary
Barratt Impulsiveness Scale-11 (BIS-11)
The BIS-11 is designed to assess the personality/behavioral impulsiveness. The BIS-11 has 30 items and is scored appropriately. Scored to yield a total score, three second-order factors, and six first-order factors. Each question has a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Higher scores mean more impulsive behavior. Total score reported (30-120).
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Barratt Impulsiveness Scale-11 (BIS-11) | Baseline | 37 score on a scale |
| HD-tDCS | Barratt Impulsiveness Scale-11 (BIS-11) | 1 Month | 35 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Barratt Impulsiveness Scale-11 (BIS-11) | Baseline | 35 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Barratt Impulsiveness Scale-11 (BIS-11) | 1 Month | 38 score on a scale |
| Personalized Beta-Gamma tACS | Barratt Impulsiveness Scale-11 (BIS-11) | Baseline | 42 score on a scale |
| Personalized Beta-Gamma tACS | Barratt Impulsiveness Scale-11 (BIS-11) | 1 Month | 40 score on a scale |
Secondary
Barratt Impulsiveness Scale-11 (BIS-11)
The BIS-11 is designed to assess the personality/behavioral impulsiveness. The BIS-11 has 30 items and is scored appropriately. Scored to yield a total score, three second-order factors, and six first-order factors. Each question has a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Higher scores mean more impulsive behavior. Total score reported (30-120).
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Barratt Impulsiveness Scale-11 (BIS-11) | Baseline | 37 score on a scale |
| HD-tDCS | Barratt Impulsiveness Scale-11 (BIS-11) | 3 Month | 35.2 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Barratt Impulsiveness Scale-11 (BIS-11) | Baseline | 35 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Barratt Impulsiveness Scale-11 (BIS-11) | 3 Month | 38 score on a scale |
| Personalized Beta-Gamma tACS | Barratt Impulsiveness Scale-11 (BIS-11) | Baseline | 42 score on a scale |
| Personalized Beta-Gamma tACS | Barratt Impulsiveness Scale-11 (BIS-11) | 3 Month | 36 score on a scale |
Secondary
Barratt Impulsiveness Scale-11 (BIS-11)
The BIS-11 is designed to assess the personality/behavioral impulsiveness. The BIS-11 has 30 items and is scored appropriately. Scored to yield a total score, three second-order factors, and six first-order factors. Each question has a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Higher scores mean more impulsive behavior. Total score reported (30-120).
Time frame: Change from baseline to 5 Day follow-up
Population: Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Barratt Impulsiveness Scale-11 (BIS-11) | Baseline | 37 score on a scale |
| HD-tDCS | Barratt Impulsiveness Scale-11 (BIS-11) | Day 5 | 38 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Barratt Impulsiveness Scale-11 (BIS-11) | Baseline | 35 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Barratt Impulsiveness Scale-11 (BIS-11) | Day 5 | 38.5 score on a scale |
| Personalized Beta-Gamma tACS | Barratt Impulsiveness Scale-11 (BIS-11) | Baseline | 42 score on a scale |
| Personalized Beta-Gamma tACS | Barratt Impulsiveness Scale-11 (BIS-11) | Day 5 | 41 score on a scale |
Secondary
Brief Assessment of Cognition (BACS)
The BACS is designed to assess several domains of cognition; Verbal Memory; Processing Speed; Working Memory; Verbal Fluency; Motor Function; Executive Functioning. Higher scores indicate better cognitive functioning. Total score reported after being transformed into z score based on normative scoring provide by test makers.
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Brief Assessment of Cognition (BACS) | Baseline | 0.44 score on a test |
| HD-tDCS | Brief Assessment of Cognition (BACS) | 3 Month | 0.18 score on a test |
| HD-tACS (Alpha, 10 Hz) | Brief Assessment of Cognition (BACS) | Baseline | -0.66 score on a test |
| HD-tACS (Alpha, 10 Hz) | Brief Assessment of Cognition (BACS) | 3 Month | -0.602 score on a test |
| Personalized Beta-Gamma tACS | Brief Assessment of Cognition (BACS) | Baseline | 0.25 score on a test |
| Personalized Beta-Gamma tACS | Brief Assessment of Cognition (BACS) | 3 Month | 0.97 score on a test |
Secondary
Brief Assessment of Cognition (BACS)
The BACS is designed to assess several domains of cognition; Verbal Memory; Processing Speed; Working Memory; Verbal Fluency; Motor Function; Executive Functioning. Higher scores indicate better cognitive functioning. Total score reported after being transformed into z score based on normative scoring provide by test makers.
Time frame: Change from baseline to 5 Day follow-up
Population: Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Brief Assessment of Cognition (BACS) | Baseline | 0.44 score on a test |
| HD-tDCS | Brief Assessment of Cognition (BACS) | Day 5 | 0.43 score on a test |
| HD-tACS (Alpha, 10 Hz) | Brief Assessment of Cognition (BACS) | Baseline | -0.66 score on a test |
| HD-tACS (Alpha, 10 Hz) | Brief Assessment of Cognition (BACS) | Day 5 | -0.74 score on a test |
| Personalized Beta-Gamma tACS | Brief Assessment of Cognition (BACS) | Baseline | 0.25 score on a test |
| Personalized Beta-Gamma tACS | Brief Assessment of Cognition (BACS) | Day 5 | 0.3 score on a test |
Secondary
Brief Assessment of Cognition (BACS)
The BACS is designed to assess several domains of cognition; Verbal Memory; Processing Speed; Working Memory; Verbal Fluency; Motor Function; Executive Functioning. Higher scores indicate better cognitive functioning. Total score reported after being transformed into z score based on normative scoring provide by test makers.
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Brief Assessment of Cognition (BACS) | Baseline | 0.44 score on a test |
| HD-tDCS | Brief Assessment of Cognition (BACS) | 1 Month | 0.01 score on a test |
| HD-tACS (Alpha, 10 Hz) | Brief Assessment of Cognition (BACS) | Baseline | -0.66 score on a test |
| HD-tACS (Alpha, 10 Hz) | Brief Assessment of Cognition (BACS) | 1 Month | -1.26 score on a test |
| Personalized Beta-Gamma tACS | Brief Assessment of Cognition (BACS) | Baseline | 0.25 score on a test |
| Personalized Beta-Gamma tACS | Brief Assessment of Cognition (BACS) | 1 Month | 0.74 score on a test |
Secondary
Electroencephalography (EEG) Resting State
Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Time frame: Change from baseline to 5 Day follow-up
Population: Delta/Theta represents the range of 2-7Hz
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Electroencephalography (EEG) Resting State | Day 5 Gamma | -20.695 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Delta/Theta | -9.261 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Gamma | -21.651 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Day 5 Beta | -17.898 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Alpha | -13.336 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Day 5 Delta/Theta | -8.844 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Beta | -17.191 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Day 5 Alpha | -12.946 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Alpha | -8.834 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Day 5 Alpha | -8.241 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Delta/Theta | -7.555 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Day 5 Gamma | -16.232 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Day 5 Beta | -12.266 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Beta | -11.636 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Gamma | -17.087 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Day 5 Delta/Theta | -3.373 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Day 5 Gamma | -22.996 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Delta/Theta | -6.410 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Alpha | -11.185 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Beta | -17.344 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Gamma | -24.011 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Day 5 Delta/Theta | -3.567 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Day 5 Alpha | -8.445 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Day 5 Beta | -16.360 peak amplitude measured in microvolts |
Secondary
Electroencephalography (EEG) Resting State
Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data. Delta/Theta represents the range of 2-7Hz.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Beta | -17.191 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Delta/Theta | -9.261 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Alpha | -13.336 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Gamma | -21.651 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | 3 Month Delta/Theta | -8.764 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | 3 Month Alpha | -14.041 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | 3 Month Beta | -17.323 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | 3 Month Gamma | -21.479 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Beta | -11.636 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | 3 Month Beta | -13.074 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Gamma | -17.087 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | 3 Month Delta/Theta | -7.362 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | 3 Month Alpha | -10.615 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Delta/Theta | -7.555 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | 3 Month Gamma | -19.348 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Alpha | -8.834 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Alpha | -11.185 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | 3 Month Alpha | -7.918 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Beta | -17.344 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Gamma | -24.011 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | 3 Month Beta | -17.643 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Delta/Theta | -6.410 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | 3 Month Delta/Theta | -3.686 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | 3 Month Gamma | -23.863 peak amplitude measured in microvolts |
Secondary
Electroencephalography (EEG) Resting State
Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individual's 1 Month Data. Delta/Theta represents the range of 2-7Hz.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Delta/Theta | -9.261 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Alpha | -13.336 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Beta | -17.191 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | Baseline Gamma | -21.651 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | 1 Month Delta/Theta | -9.775 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | 1 Month Alpha | -14.921 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | 1 Month Beta | -16.627 peak amplitude measured in microvolts |
| HD-tDCS | Electroencephalography (EEG) Resting State | 1 Month Gamma | -19.358 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Beta | -11.636 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | 1 Month Beta | -13.489 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Gamma | -17.087 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | 1 Month Delta/Theta | -8.373 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | 1 Month Alpha | -11.520 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Delta/Theta | -7.555 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | Baseline Alpha | -8.834 peak amplitude measured in microvolts |
| HD-tACS (Alpha, 10 Hz) | Electroencephalography (EEG) Resting State | 1 Month Gamma | -19.739 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Beta | -17.344 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Alpha | -11.185 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Delta/Theta | -6.410 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | Baseline Gamma | -24.011 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | 1 Month Beta | -17.502 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | 1 Month Alpha | -10.646 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | 1 Month Delta/Theta | -4.015 peak amplitude measured in microvolts |
| Personalized Beta-Gamma tACS | Electroencephalography (EEG) Resting State | 1 Month Gamma | -22.594 peak amplitude measured in microvolts |
Secondary
Global Assessment of Functioning (GAF)
The GAF measures how symptoms affect individuals day-to-day life; scored from 0 to 100
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Global Assessment of Functioning (GAF) | Baseline | 65 score on a scale |
| HD-tDCS | Global Assessment of Functioning (GAF) | 3 Month | 65 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Global Assessment of Functioning (GAF) | Baseline | 46 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Global Assessment of Functioning (GAF) | 3 Month | 52.1 score on a scale |
| Personalized Beta-Gamma tACS | Global Assessment of Functioning (GAF) | Baseline | 59 score on a scale |
| Personalized Beta-Gamma tACS | Global Assessment of Functioning (GAF) | 3 Month | 61 score on a scale |
Secondary
Global Assessment of Functioning (GAF)
The GAF measures how symptoms affect individuals day-to-day life; scored from 0 to 100
Time frame: Change from baseline to 5 Day follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Global Assessment of Functioning (GAF) | Baseline | 65 score on a scale |
| HD-tDCS | Global Assessment of Functioning (GAF) | Day 5 | 61 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Global Assessment of Functioning (GAF) | Baseline | 46 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Global Assessment of Functioning (GAF) | Day 5 | 50.5 score on a scale |
| Personalized Beta-Gamma tACS | Global Assessment of Functioning (GAF) | Baseline | 59 score on a scale |
| Personalized Beta-Gamma tACS | Global Assessment of Functioning (GAF) | Day 5 | 60 score on a scale |
Secondary
Global Assessment of Functioning (GAF)
The GAF measures how symptoms affect individuals day-to-day life; scored from 0 to 100
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individual's 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Global Assessment of Functioning (GAF) | Baseline | 65 score on a scale |
| HD-tDCS | Global Assessment of Functioning (GAF) | 1 Month | 67 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Global Assessment of Functioning (GAF) | Baseline | 46 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Global Assessment of Functioning (GAF) | 1 Month | 51 score on a scale |
| Personalized Beta-Gamma tACS | Global Assessment of Functioning (GAF) | Baseline | 59 score on a scale |
| Personalized Beta-Gamma tACS | Global Assessment of Functioning (GAF) | 1 Month | 55 score on a scale |
Secondary
Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is designed to measure depression and severity of symptoms; 0 to 6 indicates no depression, 7 to 19 indicates mild depression, 20 to 34 indicates moderate depression, 35 and greater indicates severe depression. Total score reported (0 to 60).
Time frame: Change from baseline to 5 Day follow-up
Population: Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | 8 score on a scale |
| HD-tDCS | Montgomery-Åsberg Depression Rating Scale (MADRS) | Day 5 | 7 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | 17.5 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Montgomery-Åsberg Depression Rating Scale (MADRS) | Day 5 | 14.5 score on a scale |
| Personalized Beta-Gamma tACS | Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | 10 score on a scale |
| Personalized Beta-Gamma tACS | Montgomery-Åsberg Depression Rating Scale (MADRS) | Day 5 | 7 score on a scale |
Secondary
Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is designed to measure depression and severity of symptoms; 0 to 6 indicates no depression, 7 to 19 indicates mild depression, 20 to 34 indicates moderate depression, 35 and greater indicates severe depression. Total score reported (0 to 60).
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | 8 score on a scale |
| HD-tDCS | Montgomery-Åsberg Depression Rating Scale (MADRS) | 3 Month | 8 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | 17.5 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Montgomery-Åsberg Depression Rating Scale (MADRS) | 3 Month | 19.2 score on a scale |
| Personalized Beta-Gamma tACS | Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | 10 score on a scale |
| Personalized Beta-Gamma tACS | Montgomery-Åsberg Depression Rating Scale (MADRS) | 3 Month | 6 score on a scale |
Secondary
Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is designed to measure depression and severity of symptoms; 0 to 6 indicates no depression, 7 to 19 indicates mild depression, 20 to 34 indicates moderate depression, 35 and greater indicates severe depression. Total score reported (0 to 60).
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | 8 score on a scale |
| HD-tDCS | Montgomery-Åsberg Depression Rating Scale (MADRS) | 1 Month | 7 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | 17.5 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Montgomery-Åsberg Depression Rating Scale (MADRS) | 1 Month | 16 score on a scale |
| Personalized Beta-Gamma tACS | Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | 10 score on a scale |
| Personalized Beta-Gamma tACS | Montgomery-Åsberg Depression Rating Scale (MADRS) | 1 Month | 8 score on a scale |
Secondary
Positive and Negative Syndrome Scale (PANSS)
30 items included in the PANSS measuring positive, negative and general symptoms; 7 related to positive symptoms, 7 for negative symptoms, and 16 for general psychopathology Scale. Ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Scores summed for Total Score on scale (30 to 210). Higher scores mean worse clinical symptoms. Total score reported.
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individuals 1 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Positive and Negative Syndrome Scale (PANSS) | Baseline | 49 score on a scale |
| HD-tDCS | Positive and Negative Syndrome Scale (PANSS) | 1 Month | 50 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Positive and Negative Syndrome Scale (PANSS) | Baseline | 71 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Positive and Negative Syndrome Scale (PANSS) | 1 Month | 75 score on a scale |
| Personalized Beta-Gamma tACS | Positive and Negative Syndrome Scale (PANSS) | Baseline | 68 score on a scale |
| Personalized Beta-Gamma tACS | Positive and Negative Syndrome Scale (PANSS) | 1 Month | 55 score on a scale |
Secondary
Positive and Negative Syndrome Scale (PANSS)
30 items included in the PANSS measuring positive, negative and general symptoms; 7 related to positive symptoms, 7 for negative symptoms, and 16 for general psychopathology Scale. Ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Scores summed for Total Score on scale (30 to 210). Higher scores mean worse clinical symptoms. Total score reported.
Time frame: Change from baseline to 5 Day follow-up
Population: Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Positive and Negative Syndrome Scale (PANSS) | Baseline | 49 score on a scale |
| HD-tDCS | Positive and Negative Syndrome Scale (PANSS) | Day 5 | 52 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Positive and Negative Syndrome Scale (PANSS) | Baseline | 71 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Positive and Negative Syndrome Scale (PANSS) | Day 5 | 74.5 score on a scale |
| Personalized Beta-Gamma tACS | Positive and Negative Syndrome Scale (PANSS) | Baseline | 68 score on a scale |
| Personalized Beta-Gamma tACS | Positive and Negative Syndrome Scale (PANSS) | Day 5 | 56 score on a scale |
Secondary
Positive and Negative Syndrome Scale (PANSS)
30 items included in the PANSS measuring positive, negative and general symptoms; 7 related to positive symptoms, 7 for negative symptoms, and 16 for general psychopathology Scale. Ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Scores summed for Total Score on scale (30 to 210). Higher scores mean worse clinical symptoms. Total score reported.
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Positive and Negative Syndrome Scale (PANSS) | Baseline | 49 score on a scale |
| HD-tDCS | Positive and Negative Syndrome Scale (PANSS) | 3 Month | 54.8 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Positive and Negative Syndrome Scale (PANSS) | Baseline | 71 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Positive and Negative Syndrome Scale (PANSS) | 3 Month | 73.3 score on a scale |
| Personalized Beta-Gamma tACS | Positive and Negative Syndrome Scale (PANSS) | Baseline | 68 score on a scale |
| Personalized Beta-Gamma tACS | Positive and Negative Syndrome Scale (PANSS) | 3 Month | 52 score on a scale |
Secondary
Reinforcement Learning Task
The reinforcement learning task is a monetary based learning tasks that included reward and punishment trails. The task presents multiple trials of stimuli where the participant chooses 1 of 2 stimuli presented at a time (one of which is associated with punishment represented by loss of monetary reward while the other is associated with gain of monetary reward). EEG is record during the task and signal is captured during the participants choose and the feedback received. Reported is the peak beta/gamma range response derived from the EEG during reward feedback. This measurement is used from the baseline assessment to inform the personalized beta-gamma range stimulation for the Personalized Beta-Gamma tACS group.
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used for imputing 5 individuals 3 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Reinforcement Learning Task | Baseline | 26 peak frequency measured in hertz |
| HD-tDCS | Reinforcement Learning Task | 3 Month | 25.5 peak frequency measured in hertz |
| HD-tACS (Alpha, 10 Hz) | Reinforcement Learning Task | Baseline | 25.25 peak frequency measured in hertz |
| HD-tACS (Alpha, 10 Hz) | Reinforcement Learning Task | 3 Month | 29.25 peak frequency measured in hertz |
| Personalized Beta-Gamma tACS | Reinforcement Learning Task | Baseline | 32 peak frequency measured in hertz |
| Personalized Beta-Gamma tACS | Reinforcement Learning Task | 3 Month | 27.5 peak frequency measured in hertz |
Secondary
Reinforcement Learning Task
The reinforcement learning task is a monetary based learning tasks that included reward and punishment trails. The task presents multiple trials of stimuli where the participant chooses 1 of 2 stimuli presented at a time (one of which is associated with punishment represented by loss of monetary reward while the other is associated with gain of monetary reward). EEG is record during the task and signal is captured during the participants choose and the feedback received. Reported is the peak beta/gamma range response derived from the EEG during reward feedback. This measurement is used from the baseline assessment to inform the personalized beta-gamma range stimulation for the Personalized Beta-Gamma tACS group.
Time frame: Change from baseline to 5 Day follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Reinforcement Learning Task | Baseline | 26 peak frequency measured in hertz |
| HD-tDCS | Reinforcement Learning Task | Day 5 | 28.5 peak frequency measured in hertz |
| HD-tACS (Alpha, 10 Hz) | Reinforcement Learning Task | Baseline | 25.25 peak frequency measured in hertz |
| HD-tACS (Alpha, 10 Hz) | Reinforcement Learning Task | Day 5 | 33.75 peak frequency measured in hertz |
| Personalized Beta-Gamma tACS | Reinforcement Learning Task | Baseline | 32 peak frequency measured in hertz |
| Personalized Beta-Gamma tACS | Reinforcement Learning Task | Day 5 | 22 peak frequency measured in hertz |
Secondary
Reinforcement Learning Task
The reinforcement learning task is a monetary based learning tasks that included reward and punishment trails. The task presents multiple trials of stimuli where the participant chooses 1 of 2 stimuli presented at a time (one of which is associated with punishment represented by loss of monetary reward while the other is associated with gain of monetary reward). EEG is record during the task and signal is captured during the participants choose and the feedback received. Reported is the peak beta/gamma range response derived from the EEG during reward feedback. This measurement is used from the baseline assessment to inform the personalized beta-gamma range stimulation for the Personalized Beta-Gamma tACS group.
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individual's 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Reinforcement Learning Task | Baseline | 26 peak frequency measured in hertz |
| HD-tDCS | Reinforcement Learning Task | 1 Month | 25 peak frequency measured in hertz |
| HD-tACS (Alpha, 10 Hz) | Reinforcement Learning Task | Baseline | 25.25 peak frequency measured in hertz |
| HD-tACS (Alpha, 10 Hz) | Reinforcement Learning Task | 1 Month | 28.75 peak frequency measured in hertz |
| Personalized Beta-Gamma tACS | Reinforcement Learning Task | Baseline | 32 peak frequency measured in hertz |
| Personalized Beta-Gamma tACS | Reinforcement Learning Task | 1 Month | 27.5 peak frequency measured in hertz |
Secondary
Social Functioning Scale (SFS)
The SFS a self-report questionnaire initially designed for people diagnosed with Schizophrenia; consists of 79 items designed to reflect the social skills and performances in different areas of life. Subscores are summed together for a total score. Total score of SFS ranges between 0-223 points. Higher scores mean better social functioning.
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Social Functioning Scale (SFS) | Baseline | 161 score on a scale |
| HD-tDCS | Social Functioning Scale (SFS) | 3 Month | 156.6 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Social Functioning Scale (SFS) | Baseline | 125.5 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Social Functioning Scale (SFS) | 3 Month | 127.2 score on a scale |
| Personalized Beta-Gamma tACS | Social Functioning Scale (SFS) | Baseline | 142 score on a scale |
| Personalized Beta-Gamma tACS | Social Functioning Scale (SFS) | 3 Month | 150 score on a scale |
Secondary
Social Functioning Scale (SFS)
The SFS a self-report questionnaire initially designed for people diagnosed with Schizophrenia; consists of 79 items designed to reflect the social skills and performances in different areas of life. Subscores are summed together for a total score. Total score of SFS ranges between 0-223 points. Higher scores mean better social functioning.
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Social Functioning Scale (SFS) | Baseline | 161 score on a scale |
| HD-tDCS | Social Functioning Scale (SFS) | 1 Month | 160 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Social Functioning Scale (SFS) | Baseline | 125.5 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Social Functioning Scale (SFS) | 1 Month | 130.5 score on a scale |
| Personalized Beta-Gamma tACS | Social Functioning Scale (SFS) | Baseline | 142 score on a scale |
| Personalized Beta-Gamma tACS | Social Functioning Scale (SFS) | 1 Month | 134 score on a scale |
Secondary
Social Functioning Scale (SFS)
The SFS a self-report questionnaire initially designed for people diagnosed with Schizophrenia; consists of 79 items designed to reflect the social skills and performances in different areas of life. Subscores are summed together for a total score. Total score of SFS ranges between 0-223 points. Higher scores mean better social functioning.
Time frame: Change from baseline to 5 Day follow-up
Population: Total score reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | Social Functioning Scale (SFS) | Day 5 | 159 score on a scale |
| HD-tDCS | Social Functioning Scale (SFS) | Baseline | 161 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Social Functioning Scale (SFS) | Baseline | 125.5 score on a scale |
| HD-tACS (Alpha, 10 Hz) | Social Functioning Scale (SFS) | Day 5 | 125.7 score on a scale |
| Personalized Beta-Gamma tACS | Social Functioning Scale (SFS) | Baseline | 142 score on a scale |
| Personalized Beta-Gamma tACS | Social Functioning Scale (SFS) | Day 5 | 144 score on a scale |
Secondary
The Go/No Go Task
The Go/No Go Task is a computerized task that measures impulsiveness. Participants presented with Go (to respond) and no Go (when not to respond) instructions. Two trials are performed. The first trial consist of two distinct auditory stimuli (both Go stimuli) where the participant is asked to respond with a different number of mouse clicks to the stimuli respectively. The second trial, has a no Go stimuli (where the participant is suppose to withhold a response) and a go stimuli. Reaction time for correct trials only for the entire task are reported in milliseconds.
Time frame: Change from baseline to 5 Day follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | The Go/No Go Task | Baseline | 876.9768638 reaction time (ms) on task |
| HD-tDCS | The Go/No Go Task | Day 5 | 927.1679389 reaction time (ms) on task |
| HD-tACS (Alpha, 10 Hz) | The Go/No Go Task | Baseline | 954.3716154 reaction time (ms) on task |
| HD-tACS (Alpha, 10 Hz) | The Go/No Go Task | Day 5 | 878.0193364 reaction time (ms) on task |
| Personalized Beta-Gamma tACS | The Go/No Go Task | Baseline | 859.6685714 reaction time (ms) on task |
| Personalized Beta-Gamma tACS | The Go/No Go Task | Day 5 | 917.7871795 reaction time (ms) on task |
Secondary
The Go/No Go Task
The Go/No Go Task is a computerized task that measures impulsiveness. Participants presented with Go (to respond) and no Go (when not to respond) instructions. Two trials are performed. The first trial consist of two distinct auditory stimuli (both Go stimuli) where the participant is asked to respond with a different number of mouse clicks to the stimuli respectively. The second trial, has a no Go stimuli (where the participant is suppose to withhold a response) and a go stimuli. Reaction time for correct trials only for the entire task are reported in milliseconds.
Time frame: Change from baseline to 1-month follow-up
Population: 'Mice' R package used for 1 individual's 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | The Go/No Go Task | Baseline | 876.9768638 reaction time (ms) on task |
| HD-tDCS | The Go/No Go Task | 1 Month | 923.5850515 reaction time (ms) on task |
| HD-tACS (Alpha, 10 Hz) | The Go/No Go Task | Baseline | 954.3716154 reaction time (ms) on task |
| HD-tACS (Alpha, 10 Hz) | The Go/No Go Task | 1 Month | 919.8986144 reaction time (ms) on task |
| Personalized Beta-Gamma tACS | The Go/No Go Task | Baseline | 859.6685714 reaction time (ms) on task |
| Personalized Beta-Gamma tACS | The Go/No Go Task | 1 Month | 880.3450882 reaction time (ms) on task |
Secondary
The Go/No Go Task
The Go/No Go Task is a computerized task that measures impulsiveness. Participants presented with Go (to respond) and no Go (when not to respond) instructions. Two trials are performed. The first trial consist of two distinct auditory stimuli (both Go stimuli) where the participant is asked to respond with a different number of mouse clicks to the stimuli respectively. The second trial, has a no Go stimuli (where the participant is suppose to withhold a response) and a go stimuli. Reaction time for correct trials only for the entire task are reported in milliseconds.
Time frame: Change from baseline to 3-month follow-up
Population: 'Mice' R package used to impute 5 individuals 3 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD-tDCS | The Go/No Go Task | Baseline | 876.9768638 reaction time (ms) on task |
| HD-tDCS | The Go/No Go Task | 3 Month | 931.8461538 reaction time (ms) on task |
| HD-tACS (Alpha, 10 Hz) | The Go/No Go Task | Baseline | 954.3716154 reaction time (ms) on task |
| HD-tACS (Alpha, 10 Hz) | The Go/No Go Task | 3 Month | 925.0182573 reaction time (ms) on task |
| Personalized Beta-Gamma tACS | The Go/No Go Task | Baseline | 859.6685714 reaction time (ms) on task |
| Personalized Beta-Gamma tACS | The Go/No Go Task | 3 Month | 845.64 reaction time (ms) on task |