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

NCT ID: NCT01860677

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2014-06-30

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.

Conditions

Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active stimulation

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.

Group Type: ACTIVE_COMPARATOR

Fisher Wallace Cranial Stimulator

Intervention Type: DEVICE

The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.

Sham stimulation

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

Group Type: PLACEBO_COMPARATOR

Fisher Wallace Cranial Stimulator

Intervention Type: DEVICE

The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.

Interventions

Fisher Wallace Cranial Stimulator

The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mending Minds Foundation

UNKNOWN

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Scott Lukas

Director, McLean Imaging Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott E Lukas, PhD

Role: PRINCIPAL_INVESTIGATOR

McLean Imaging Center, McLean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

References

Gilula MF, Barach PR. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. South Med J. 2004 Dec;97(12):1269-70. doi: 10.1097/01.SMJ.0000136304.33212.06. No abstract available.

Reference Type: BACKGROUND

PMID: 15646771 (View on PubMed)

Smith RB (2006) Cranial electrotherapy stimulation: Its first fifty years, plus three: a monograph. Oklahoma: Tate Publishing & Enterprises

Reference Type: BACKGROUND

Other Identifiers

P-001567

Identifier Type: -

Identifier Source: org_study_id