The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood

Study Overview
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Brief Summary
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Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.

Detailed Description
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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.

Official Title
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The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood: An fMRI/MRS Study

Conditions
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Mood

Intervention / Treatment
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* Device: Fisher Wallace Cranial Stimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active stimulation<br>The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA. | Device: Fisher Wallace Cranial Stimulator<br>* The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.<br>|
| Placebo Comparator: Sham stimulation<br>Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. | Device: Fisher Wallace Cranial Stimulator<br>* The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment | 
| 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. | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment | 
| 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. | within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cranial stimulation, BOLD (Blood Oxygenation Level Dependent), fMRI (Functional Magnetic Resonance Imaging), spectroscopy