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

Mass General Brigham

Status: Completed

Conditions: Mood

Treatments: Device: Fisher Wallace Cranial Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT01860677

P-001567

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Active stimulation

Active Comparator group

Description:

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.

Treatment:

Device: Fisher Wallace Cranial Stimulator

Sham stimulation

Placebo Comparator group

Description:

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

Treatment:

Device: Fisher Wallace Cranial Stimulator