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

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

Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.

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.

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