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

Not Applicable

Completed

Conditions: Mood

Interventions: Device: Fisher Wallace Cranial Stimulator

Registration Number: NCT01860677

Lead Sponsor: Mclean Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active stimulation	Fisher Wallace Cranial Stimulator	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.
Sham stimulation	Fisher Wallace Cranial Stimulator	Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.