Status:
COMPLETED
The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Mending Minds Foundation
Conditions:
Mood
Eligibility:
All Genders
21-55 years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01860677
Start Date
May 1 2010
End Date
June 1 2014
Last Update
June 14 2017
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478