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

Completed · Not applicable · Has a placebo group

Conditions studied: Mood

In brief

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

Key facts

Study ID: NCT01860677
Run by: Mclean Hospital
People needed: 8
Starts: 2010-05-01
Expected to finish: 2014-06-01
Last updated by the study team: 2017-06-14

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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