Hallucinations, Auditory, Psychosis
Conditions
Keywords
Transcranial Electrical Stimulation, Electroencephalography
Brief summary
Hallucinations are a core diagnostic feature of psychotic disorders. They involve different sensory modalities, including auditory, visual, olfactory, tactile, and gustatory hallucinations, among others. Hallucinations occur in multiple different neurological and psychiatric illnesses and can be refractory to existing treatments. Auditory hallucinations and visual hallucinations are found across diagnostic categories of psychotic disorders (schizophrenia, schizoaffective, bipolar disorder). Despite visual hallucinations being approximately half as frequent as auditory hallucinations, they almost always co-occur with auditory hallucinations, and are linked to a more severe psychopathological profile. Auditory and visual hallucinations at baseline also predict higher disability, risk of relapse and duration of psychosis after 1 and 2 years, especially when they occur in combination. Using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions connected to the right superior temporal sulcus (rSTS) plays a causal role in the development of hallucinations. The rSTS receives convergent somatosensory, auditory, and visual inputs, and is regarded as a site for multimodal sensory integration. Here the investigators aim to answer the question whether noninvasive brain stimulation when optimally targeted to the rSTS can improve brain activity, sensory integration, and hallucinations.
Detailed description
Functional neuroimaging studies have identified neural correlates of hallucinations across multiple brain regions. Some studies suggest a common neuroanatomical substrate independent of the sensory modality, while others suggest different neural correlates for different types of hallucinations. However, whether these neuroimaging findings represented a cause, consequence or epiphenomenon of hallucinations was unclear until recently. Using lesion network mapping, researchers demonstrated that focal brain lesions play a causal role in the development of hallucinations and can occur in different brain locations, both inside and outside sensory pathway, and that greater than 90% of lesion locations causing hallucinations are negatively connected to the right superior temporal sulcus (rSTS). The rSTS is known to play a role in social cognition, biological motion, audiovisual integration, and speech. Hence, when spontaneous activity decreases at lesion locations causing hallucinations, spontaneous activity in the rSTS increases, the exact pattern thought to predispose to hallucinations. Additionally, functional connectivity within this region is abnormal in patients with visual and auditory hallucinations. Therefore, the association between rSTS connectivity and hallucinations would suggest this region may be optimal for modulation via non-invasive brain stimulation. One method by which cortical excitability can be altered is with transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique. High definition tDCS (HD-tDCS) is a refined version of tDCS with improved spatial precision of cortical stimulation. This involves the application of a weak electrical current (1-2 mA) delivered to the brain via scalp electrodes. tDCS can modulate cortical excitability, where anodal stimulation tends to increase (i.e. the resting potential becomes less negative) and cathodal stimulation tends to decrease the underlying membrane potential (i.e. the resting potential becomes more negative). While tDCS is a promising adjunctive treatment of auditory hallucinations and negative symptoms in schizophrenia, less is known about its role in treating hallucinations overall. To date, no study has non-invasively stimulated the rSTS with tDCS in psychosis and examined its effects on hallucinations. However, there are studies in healthy volunteers showing that anodal stimulation to the STS resulted in increased auditory false perceptions, while cathodal stimulation decreased false perceptions and was lower than the sham condition. Taken together, the recent lesion network mapping identifying the rSTS as a major source of hallucinations combined with prior studies showing that the rSTS is associated with hallucinations suggest that it may be possible to alleviate hallucinations by designing a tDCS protocol that targets the rSTS with cathodal stimulation. Technological advances in noninvasive neuromodulation and electrical field modeling further allow us to create a tDCS protocol specifically guided by the results of lesion network mapping studies with high spatial resolution.
Interventions
DEVICETranscranial Electrical Stimulation
Transcranial electrical stimulation
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-50 years of age 2. Proficient in English 3. Able to give informed consent 4. Actively experiencing hallucinations (tactile, auditory, visual, etc.) 5. 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 |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | Change from baseline to day 5 | Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms |
| University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) | Change from baseline to day 5 | Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms. Total quantitative score (min = 0; max = 14). |
| 7-item Auditory Hallucinations Rating Scale (AHRS) | Change from baseline to day 5 | Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms. Total score (0-41). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting State EEG | Change from baseline to 5 day | 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. |
| Biological Motion | Change from baseline to 5 day | Measuring the percent correct of detected motion by presenting a simulated walker; difficulty is increased by the level of random noise around stimuli. 20 trials are presented. Higher scores (0-100%) indicate a better ability to detect motion. |
| Neurological Evaluation Scale; Sensory Integration | Change from baseline to 5 day | Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns |
| Global Assessment of Function (GAF) | Change from baseline to day 5 | Measuring global functioning; severity of symptoms related to day-to-day life on a scale of 0 to 100; higher scores represent higher severity of symptoms |
| Auditory Steady State Evoked Potential | Change from baseline to day 5 | Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular auditory frequency of interest. |
| Young Mania Rating Scale (YMRS) | Change from baseline to 5 day | Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms |
| Brief Assessment of Cognition (BACS) | Change from baseline to 5 day | Measuring cognition; cognitive domains assessed include memory, working memory, processing speed, executive functions and verbal fluency. Higher scores indicate greater cognitive ability on a given task. |
| Symptom Checklist-90 | Change from baseline to 5 day | Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms. Total score range 0 to 360 |
| Montgomery-Asberg Depression Rating Scale (MADRS) | Change from baseline to 5 day | Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms |
| Steady State Visual Evoked Potential | Change from baseline to day 5 | Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual frequency of interest. |
| Cross Modal Steady State Evoked Potential | Change from baseline to day 5 | Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual/auditory frequency of interest. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through patient conversations and advertisements.
Pre-assignment details
Individuals performed a full clinical assessment including a structured clinical interview and medical history review to confirm diagnosis. Individuals were required to have a history or current hallucinations (visual, auditory, tactile, etc.) to participate in the study. Participants were then randomized to one of the two arms of the study (active tDCS or sham) targeting the right superior temporal sulcus.
Participants by arm
| Arm | Count |
|---|---|
| Active Stimulation With TDCS tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation | 6 |
| SHAM Stimulation Passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
Transcranial Electrical Stimulation: Transcranial electrical stimulation | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | SHAM Stimulation | Total | Active Stimulation With TDCS |
|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 14.8 | 37.1 years STANDARD_DEVIATION 11.5 | 36.7 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 11 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Prior/Current Hallucinations | 6 Participants | 12 Participants | 6 Participants |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
7-item Auditory Hallucinations Rating Scale (AHRS)
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms. Total score (0-41).
Time frame: Change from baseline to month follow-up
Population: Total score reported (0-41)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | 7-item Auditory Hallucinations Rating Scale (AHRS) | Baseline | 0 score on a scale |
| Active Stimulation With TDCS | 7-item Auditory Hallucinations Rating Scale (AHRS) | 1 Month | 0 score on a scale |
| SHAM Stimulation | 7-item Auditory Hallucinations Rating Scale (AHRS) | Baseline | 8 score on a scale |
| SHAM Stimulation | 7-item Auditory Hallucinations Rating Scale (AHRS) | 1 Month | 6 score on a scale |
Primary
7-item Auditory Hallucinations Rating Scale (AHRS)
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms. Total score (0-41).
Time frame: Change from baseline to day 5
Population: Total score reported (0-41).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | 7-item Auditory Hallucinations Rating Scale (AHRS) | Baseline | 0 score on a scale |
| Active Stimulation With TDCS | 7-item Auditory Hallucinations Rating Scale (AHRS) | Day 5 | 0 score on a scale |
| SHAM Stimulation | 7-item Auditory Hallucinations Rating Scale (AHRS) | Baseline | 8 score on a scale |
| SHAM Stimulation | 7-item Auditory Hallucinations Rating Scale (AHRS) | Day 5 | 6 score on a scale |
Primary
Positive and Negative Syndrome Scale (PANSS)
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
Time frame: Change from baseline to day 5
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Positive and Negative Syndrome Scale (PANSS) | Baseline | 60.5 score on a scale |
| Active Stimulation With TDCS | Positive and Negative Syndrome Scale (PANSS) | Day 5 | 56 score on a scale |
| SHAM Stimulation | Positive and Negative Syndrome Scale (PANSS) | Baseline | 60 score on a scale |
| SHAM Stimulation | Positive and Negative Syndrome Scale (PANSS) | Day 5 | 63 score on a scale |
Primary
Positive and Negative Syndrome Scale (PANSS)
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
Time frame: Change from baseline to month follow-up
Population: 'Mice' R package used for multiple imputation on 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Positive and Negative Syndrome Scale (PANSS) | Baseline | 60.5 score on a scale |
| Active Stimulation With TDCS | Positive and Negative Syndrome Scale (PANSS) | 1 Month | 58.5 score on a scale |
| SHAM Stimulation | Positive and Negative Syndrome Scale (PANSS) | Baseline | 60 score on a scale |
| SHAM Stimulation | Positive and Negative Syndrome Scale (PANSS) | 1 Month | 70.5 score on a scale |
Primary
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms. Total quantitative score (min = 0; max = 14).
Time frame: Change from baseline to month follow-up
Population: Total quantitative score reported (min = 0; max = 14)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) | Baseline | 1.85 score on a scale |
| Active Stimulation With TDCS | University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) | 1 Month | 1.4 score on a scale |
| SHAM Stimulation | University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) | Baseline | 1.9 score on a scale |
| SHAM Stimulation | University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) | 1 Month | 2.35 score on a scale |
Primary
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms. Total quantitative score (min = 0; max = 14).
Time frame: Change from baseline to day 5
Population: Total quantitative score reported (min = 0; max = 14)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) | Baseline | 1.85 score on a scale |
| Active Stimulation With TDCS | University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) | Day 5 | 1.3 score on a scale |
| SHAM Stimulation | University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) | Baseline | 1.9 score on a scale |
| SHAM Stimulation | University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) | Day 5 | 2 score on a scale |
Secondary
Auditory Steady State Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular auditory frequency of interest.
Time frame: Change from baseline to day 5
Population: 1 individual in the active TDCS group had unusable data due to poor data quality.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Auditory Steady State Evoked Potential | Baseline | 0.369044853 decibels |
| Active Stimulation With TDCS | Auditory Steady State Evoked Potential | Day | 0.259385513 decibels |
| SHAM Stimulation | Auditory Steady State Evoked Potential | Baseline | 0.434681797 decibels |
| SHAM Stimulation | Auditory Steady State Evoked Potential | Day | 0.257550439 decibels |
Secondary
Auditory Steady State Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular auditory frequency of interest.
Time frame: Change from baseline to month follow-up
Population: 1 individual in the active TDCS group had unusable data due to poor data quality.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Auditory Steady State Evoked Potential | Baseline | 0.369044853 decibels |
| Active Stimulation With TDCS | Auditory Steady State Evoked Potential | 1 Month | 0.307252913 decibels |
| SHAM Stimulation | Auditory Steady State Evoked Potential | Baseline | 0.434681797 decibels |
| SHAM Stimulation | Auditory Steady State Evoked Potential | 1 Month | 0.221649958 decibels |
Secondary
Biological Motion
Measuring the percent correct of detected motion by presenting a simulated walker; difficulty is increased by the level of random noise around stimuli. 20 trials are presented. Higher scores (0-100%) indicate a better ability to detect motion.
Time frame: Change from baseline to 5 day
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Biological Motion | Baseline | 87.5 percentage correct |
| Active Stimulation With TDCS | Biological Motion | Day 5 | 95 percentage correct |
| SHAM Stimulation | Biological Motion | Baseline | 85 percentage correct |
| SHAM Stimulation | Biological Motion | Day 5 | 72.5 percentage correct |
Secondary
Biological Motion
Measuring the percent correct of detected motion by presenting a simulated walker; difficulty is increased by the level of random noise around stimuli. 20 trials are presented. Higher scores (0-100%) indicate a better ability to detect motion.
Time frame: Change from baseline to month follow-up
Population: 'Mice' R package used for multiple imputation of 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Biological Motion | Baseline | 87.5 percentage correct |
| Active Stimulation With TDCS | Biological Motion | 1 Month | 95 percentage correct |
| SHAM Stimulation | Biological Motion | Baseline | 85 percentage correct |
| SHAM Stimulation | Biological Motion | 1 Month | 85 percentage correct |
Secondary
Brief Assessment of Cognition (BACS)
Measuring cognition; cognitive domains assessed include memory, working memory, processing speed, executive functions and verbal fluency. Higher scores indicate greater cognitive ability on a given task.
Time frame: Change from baseline to month follow-up
Population: 'Mice R package used for multiple imputation on 1 Month data; BACS total score reported. BACS total score reported. Summed from all subcategories of cognition (memory, working memory, processing speed, executive function and verbal fluency scores). Scores transformed into Z scores based off standardized transformations provided by the test makers. 0 represents the population mean for healthy controls. Standard deviations above the mean represent better cognitive ability.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Brief Assessment of Cognition (BACS) | Baseline | 0.58 z score on test |
| Active Stimulation With TDCS | Brief Assessment of Cognition (BACS) | 1 Month | -0.07 z score on test |
| SHAM Stimulation | Brief Assessment of Cognition (BACS) | Baseline | -0.8 z score on test |
| SHAM Stimulation | Brief Assessment of Cognition (BACS) | 1 Month | -1.425 z score on test |
Secondary
Brief Assessment of Cognition (BACS)
Measuring cognition; cognitive domains assessed include memory, working memory, processing speed, executive functions and verbal fluency. Higher scores indicate greater cognitive ability on a given task.
Time frame: Change from baseline to 5 day
Population: BACS total score reported. Summed from all subcategories of cognition (memory, working memory, processing speed, executive function and verbal fluency scores). Scores transformed into Z scores based off standardized transformations provided by the test makers. 0 represents the population mean for healthy controls. Standard deviations above the mean represent better cognitive ability.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Brief Assessment of Cognition (BACS) | Baseline | 0.58 z score on test |
| Active Stimulation With TDCS | Brief Assessment of Cognition (BACS) | Day 5 | -0.15 z score on test |
| SHAM Stimulation | Brief Assessment of Cognition (BACS) | Baseline | -0.8 z score on test |
| SHAM Stimulation | Brief Assessment of Cognition (BACS) | Day 5 | -1.065 z score on test |
Secondary
Cross Modal Steady State Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual/auditory frequency of interest.
Time frame: Change from baseline to day 5
Population: 1 individual in the active TDCS group had unusable data due to poor data quality.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Cross Modal Steady State Evoked Potential | Baseline | -0.129873057 decibels |
| Active Stimulation With TDCS | Cross Modal Steady State Evoked Potential | Day 5 | -0.227227968 decibels |
| SHAM Stimulation | Cross Modal Steady State Evoked Potential | Baseline | -0.225582699 decibels |
| SHAM Stimulation | Cross Modal Steady State Evoked Potential | Day 5 | -0.309958523 decibels |
Secondary
Cross Modal Steady State Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual/auditory frequency of interest.
Time frame: Change from baseline to month follow-up
Population: 1 individual in the active TDCS group had unusable data due to poor data quality.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Cross Modal Steady State Evoked Potential | 1 Month | -0.372064254 decibels |
| Active Stimulation With TDCS | Cross Modal Steady State Evoked Potential | Baseline | -0.129873057 decibels |
| SHAM Stimulation | Cross Modal Steady State Evoked Potential | 1 Month | -0.370288832 decibels |
| SHAM Stimulation | Cross Modal Steady State Evoked Potential | Baseline | -0.225582699 decibels |
Secondary
Global Assessment of Function (GAF)
Measuring global functioning; severity of symptoms related to day-to-day life on a scale of 0 to 100; higher scores represent higher severity of symptoms
Time frame: Change from baseline to month follow-up
Population: 'Mice' R package used for multiple imputation on 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Global Assessment of Function (GAF) | Baseline | 60.5 score on a scale |
| Active Stimulation With TDCS | Global Assessment of Function (GAF) | 1 Month | 61.5 score on a scale |
| SHAM Stimulation | Global Assessment of Function (GAF) | Baseline | 57.5 score on a scale |
| SHAM Stimulation | Global Assessment of Function (GAF) | 1 Month | 54 score on a scale |
Secondary
Global Assessment of Function (GAF)
Measuring global functioning; severity of symptoms related to day-to-day life on a scale of 0 to 100; higher scores represent higher severity of symptoms
Time frame: Change from baseline to day 5
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Global Assessment of Function (GAF) | Baseline | 60.5 score on a scale |
| Active Stimulation With TDCS | Global Assessment of Function (GAF) | Day 5 | 60.5 score on a scale |
| SHAM Stimulation | Global Assessment of Function (GAF) | Baseline | 57.5 score on a scale |
| SHAM Stimulation | Global Assessment of Function (GAF) | Day 5 | 53 score on a scale |
Secondary
Montgomery-Asberg Depression Rating Scale (MADRS)
Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
Time frame: Change from baseline to 5 day
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline | 7 score on a scale |
| Active Stimulation With TDCS | Montgomery-Asberg Depression Rating Scale (MADRS) | Day 5 | 6 score on a scale |
| SHAM Stimulation | Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline | 7.5 score on a scale |
| SHAM Stimulation | Montgomery-Asberg Depression Rating Scale (MADRS) | Day 5 | 13.5 score on a scale |
Secondary
Montgomery-Asberg Depression Rating Scale (MADRS)
Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
Time frame: Change from baseline to month follow-up
Population: 'Mice' R package used for multiple imputation on 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline | 7 score on a scale |
| Active Stimulation With TDCS | Montgomery-Asberg Depression Rating Scale (MADRS) | 1 Month | 5.5 score on a scale |
| SHAM Stimulation | Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline | 7.5 score on a scale |
| SHAM Stimulation | Montgomery-Asberg Depression Rating Scale (MADRS) | 1 Month | 13 score on a scale |
Secondary
Neurological Evaluation Scale; Sensory Integration
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
Time frame: Change from baseline to month follow-up
Population: Data was unable to be obtained for due to the a technique problem in code for the task that resulted in incorrectly quantifying outcomes.
Secondary
Neurological Evaluation Scale; Sensory Integration
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
Time frame: Change from baseline to 5 day
Population: Data was unable to be obtained for due to the a technique problem in code for the task that resulted in incorrectly quantifying outcomes.
Secondary
Resting State EEG
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Resting State EEG | Baseline Delta/Theta Range (1-8hz) | -6.067479336 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Day 5 Delta/Theta Range (1-8hz) | -6.538377742 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Baseline Alpha (8-12hz) | -7.920960953 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Day 5 Alpha (8-12hz) | -7.433306198 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Baseline Beta (13-30hz) | -15.99107017 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Day 5 Beta (13-30hz) | -15.97882887 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Baseline Gamma (30-55hz) | -22.64365385 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Day 5 Gamma (30-55hz) | -23.79503055 microvolts |
| SHAM Stimulation | Resting State EEG | Day 5 Gamma (30-55hz) | -22.638985 microvolts |
| SHAM Stimulation | Resting State EEG | Baseline Delta/Theta Range (1-8hz) | -9.836502863 microvolts |
| SHAM Stimulation | Resting State EEG | Baseline Beta (13-30hz) | -17.88706322 microvolts |
| SHAM Stimulation | Resting State EEG | Day 5 Delta/Theta Range (1-8hz) | -8.837371992 microvolts |
| SHAM Stimulation | Resting State EEG | Baseline Gamma (30-55hz) | -22.02556837 microvolts |
| SHAM Stimulation | Resting State EEG | Baseline Alpha (8-12hz) | -11.66579035 microvolts |
| SHAM Stimulation | Resting State EEG | Day 5 Beta (13-30hz) | -17.45169236 microvolts |
| SHAM Stimulation | Resting State EEG | Day 5 Alpha (8-12hz) | -10.07675116 microvolts |
Secondary
Resting State EEG
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 month follow-up
Population: 'Mice' R package used for multiple imputation of 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Resting State EEG | Baseline Delta/Theta Range (1-8hz) | -6.067479336 microvolts |
| Active Stimulation With TDCS | Resting State EEG | 1 Month Delta/Theta Range (1-8hz) | -5.891239776 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Baseline Alpha (8-12hz) | -7.920960953 microvolts |
| Active Stimulation With TDCS | Resting State EEG | 1 Month Alpha (8-12hz) | -9.390036281 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Baseline Beta (12-30hz) | -15.99107017 microvolts |
| Active Stimulation With TDCS | Resting State EEG | 1 Month Beta (13-30hz) | -16.0281252 microvolts |
| Active Stimulation With TDCS | Resting State EEG | Baseline Gamma (30-55hz) | -22.64365385 microvolts |
| Active Stimulation With TDCS | Resting State EEG | 1 Month Gamma (30-55hz) | -23.89591029 microvolts |
| SHAM Stimulation | Resting State EEG | 1 Month Gamma (30-55hz) | -22.95515728 microvolts |
| SHAM Stimulation | Resting State EEG | Baseline Delta/Theta Range (1-8hz) | -9.836502863 microvolts |
| SHAM Stimulation | Resting State EEG | Baseline Beta (12-30hz) | -17.88706322 microvolts |
| SHAM Stimulation | Resting State EEG | 1 Month Delta/Theta Range (1-8hz) | -8.925939219 microvolts |
| SHAM Stimulation | Resting State EEG | Baseline Gamma (30-55hz) | -22.02556837 microvolts |
| SHAM Stimulation | Resting State EEG | Baseline Alpha (8-12hz) | -11.66579035 microvolts |
| SHAM Stimulation | Resting State EEG | 1 Month Beta (13-30hz) | -16.27626797 microvolts |
| SHAM Stimulation | Resting State EEG | 1 Month Alpha (8-12hz) | -7.367402407 microvolts |
Secondary
Steady State Visual Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual frequency of interest.
Time frame: Change from baseline to month follow-up
Population: 1 individual in the active TDCS group had unusable data due to poor data quality.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Steady State Visual Evoked Potential | Baseline | -0.62131125 decibels |
| Active Stimulation With TDCS | Steady State Visual Evoked Potential | 1 Month | 0.276320034 decibels |
| SHAM Stimulation | Steady State Visual Evoked Potential | Baseline | -0.046333327 decibels |
| SHAM Stimulation | Steady State Visual Evoked Potential | 1 Month | -0.342125912 decibels |
Secondary
Steady State Visual Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10\*log10) at a particular visual frequency of interest.
Time frame: Change from baseline to day 5
Population: 1 individual in the active TDCS group had unusable data due to poor data quality.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Steady State Visual Evoked Potential | Baseline | -0.62131125 decibels |
| Active Stimulation With TDCS | Steady State Visual Evoked Potential | Day 5 | -0.101487523 decibels |
| SHAM Stimulation | Steady State Visual Evoked Potential | Baseline | -0.046333327 decibels |
| SHAM Stimulation | Steady State Visual Evoked Potential | Day 5 | -0.061733608 decibels |
Secondary
Symptom Checklist-90
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms.Total score range 0 to 360.
Time frame: Change from baseline to month follow-up
Population: 'Mice' R package used for multiple imputation on missing data. Total score assesses psychological distress through 90 items reported. Total score reported, range 0 to 360.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Symptom Checklist-90 | Baseline | 56.5 score on a scale |
| Active Stimulation With TDCS | Symptom Checklist-90 | 1 Month | 42 score on a scale |
| SHAM Stimulation | Symptom Checklist-90 | Baseline | 81.5 score on a scale |
| SHAM Stimulation | Symptom Checklist-90 | 1 Month | 95.5 score on a scale |
Secondary
Symptom Checklist-90
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms. Total score range 0 to 360
Time frame: Change from baseline to 5 day
Population: Total score assesses psychological distress through 90 items reported. Total score reported, range 0 to 360.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Symptom Checklist-90 | Baseline | 56.5 score on a scale |
| Active Stimulation With TDCS | Symptom Checklist-90 | Day 5 | 33 score on a scale |
| SHAM Stimulation | Symptom Checklist-90 | Baseline | 81.5 score on a scale |
| SHAM Stimulation | Symptom Checklist-90 | Day 5 | 84.5 score on a scale |
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Young Mania Rating Scale (YMRS) | Baseline | 2.25 score on a scale |
| Active Stimulation With TDCS | Young Mania Rating Scale (YMRS) | Day 5 | 1.25 score on a scale |
| SHAM Stimulation | Young Mania Rating Scale (YMRS) | Baseline | 7 score on a scale |
| SHAM Stimulation | Young Mania Rating Scale (YMRS) | Day 5 | 14 score on a scale |
Secondary
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 month follow-up
Population: 'Mice R package used for multiple imputation on 1 Month data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Stimulation With TDCS | Young Mania Rating Scale (YMRS) | Baseline | 2.25 score on a scale |
| Active Stimulation With TDCS | Young Mania Rating Scale (YMRS) | 1 Month | 2 score on a scale |
| SHAM Stimulation | Young Mania Rating Scale (YMRS) | Baseline | 7 score on a scale |
| SHAM Stimulation | Young Mania Rating Scale (YMRS) | 1 Month | 8.75 score on a scale |