Mood
Conditions
Keywords
cranial stimulation, BOLD (Blood Oxygenation Level Dependent), fMRI (Functional Magnetic Resonance Imaging), spectroscopy
Brief summary
Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.
Detailed description
The advent of an appreciation that alternative and complementary practices can have some beneficial effect on health has prompted the question of whether there are empirical measures of improvement that do not rely solely on subjective reports. The present study proposes to explore whether transcranial stimulation (or cranial electrotherapy stimulation; CES) using an FDA-approved device can alter brain function, mood and responses to cognitive tasks.
Interventions
DEVICEFisher Wallace Cranial Stimulator
The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
Sponsors
Mending Minds Foundation
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 21 to 55 years old * Otherwise physically healthy (normal physical exam, ECG, blood and urine chemistries) * Female participants must use medically approved method of contraception. If barrier method is used, they must agree to using two methods simultaneously (e.g., diaphragm and condom). * If on antidepressant or antianxiety medication, must be on a stable prescription regimen with no intentions to change drugs or dose during the next 11 weeks.
Exclusion criteria
* Opiate maintenance (e.g., methadone or buprenorphine) * Drug use (other than nicotine, alcohol, or marihuana) greater than 50 lifetime uses. * Meets criteria for current drug abuse or dependence (other than nicotine, alcohol, or marihuana). Past abuse/dependence (greater than 3 years) is acceptable. * Meets criteria for alcohol dependence. Past abuse/dependence (greater than 3 years) is acceptable. They may meet criteria for alcohol abuse. * Physical health problems * History of significant cardiac problems * History of seizures * Pregnancy * Persons with a demand-type cardiac pacemaker * Persons receiving vagus nerve simulation * Persons receiving deep brain stimulation * Participants cannot have any conditions that are contraindicated for MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment | Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment | Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption. |
| Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment | Positive and Negative Affect Schedule (PANAS), as defined by Watson et al. (1988), range between 10 and 50 points. Anchors of not at all (10) to most ever (50) were used to rank each measure. Change compares post-treatment to pre-treatment. Positive Affects included the following terms: Attentive, Active, Alert, Excited, Enthusiastic, Determined, Inspired, Proud, Interested, and Strong. Negative Affects included the following terms: Hostile, Irritable, Ashamed, Guilty, Distressed, Upset, Scared, Afraid, Jittery, and Nervous. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome. |
| Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment | Visual Analogue Scale (VAS) ranges from 0-100. Anchors of not at all (0) to most ever (100) were used to rank the following: anxious, sleepy, dizzy, relaxed, physical symptoms, confused, sluggish, energetic, fatigued, and stressed. Change compares post-treatment to pre-treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All of the study participants | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention (1 Day) | Lost to Follow-up | 7 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 25.4 years STANDARD_DEVIATION 4.5 |
| Alcohol consumption | 2.1 alcoolic drinks/week STANDARD_DEVIATION 2.1 |
| Body Mass Index (BMI) | 24.35 kg/m^2 STANDARD_DEVIATION 4.76 |
| Caffeine consumption | 5.2 caffeinated beverages/week STANDARD_DEVIATION 6.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Marihuana use (spelling with 'h' used by DEA and FDA) | 3.5 lifetime uses STANDARD_DEVIATION 6.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 1 |
| serious Total, serious adverse events | 0 / 8 | 0 / 1 |
Outcome results
Primary
BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits
Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption.
Time frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Population: Data were not collected
Secondary
BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only
Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption.
Time frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Population: Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Stimulation | BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only | 0.2 coupling ratio | Standard Deviation 0.5 |
Secondary
Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm
Positive and Negative Affect Schedule (PANAS), as defined by Watson et al. (1988), range between 10 and 50 points. Anchors of not at all (10) to most ever (50) were used to rank each measure. Change compares post-treatment to pre-treatment. Positive Affects included the following terms: Attentive, Active, Alert, Excited, Enthusiastic, Determined, Inspired, Proud, Interested, and Strong. Negative Affects included the following terms: Hostile, Irritable, Ashamed, Guilty, Distressed, Upset, Scared, Afraid, Jittery, and Nervous. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome.
Time frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Population: Participants in the active stimulation arm. Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Stimulation | Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm | PANAS Positive Affect | 1.88 units on a scale | Standard Deviation 3.6 |
| Active Stimulation | Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm | PANAS Negative Affect | -0.63 units on a scale | Standard Deviation 0.74 |
Secondary
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Visual Analogue Scale (VAS) ranges from 0-100. Anchors of not at all (0) to most ever (100) were used to rank the following: anxious, sleepy, dizzy, relaxed, physical symptoms, confused, sluggish, energetic, fatigued, and stressed. Change compares post-treatment to pre-treatment.
Time frame: within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Population: Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.~3 participants were missing data on these measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Anxiety | -2.90 units on a scale | Standard Deviation 5.85 |
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Sleepy | 5.80 units on a scale | Standard Deviation 21.06 |
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Dizzy | 1.10 units on a scale | Standard Deviation 6.42 |
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Relaxed | -2.60 units on a scale | Standard Deviation 12.77 |
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Physical symptoms | 2.30 units on a scale | Standard Deviation 2.71 |
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Confused | 0.80 units on a scale | Standard Deviation 1.89 |
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Sluggish | -1.80 units on a scale | Standard Deviation 18.7 |
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Energetic | 0.00 units on a scale | Standard Deviation 9.56 |
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Fatigued | 3.80 units on a scale | Standard Deviation 6.52 |
| Active Stimulation | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Stressed | -3.40 units on a scale | Standard Deviation 5.67 |