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

NCT01860677 | Completed Results

• 1 other identifier: P-001567
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mood

Keywords

cranial stimulation; BOLD (Blood Oxygenation Level Dependent); fMRI (Functional Magnetic Resonance Imaging); spectroscopy

Outcome Measures

Primary Outcomes (1)

• BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits

  Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption.

  within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment

Secondary Outcomes (3)

• BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only

  within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment

• Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm

  within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment

• Change in Visual Analogue Scale (VAS) in Active Stimulation Arm

  within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

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.

Device: Fisher Wallace Cranial Stimulator

Sham stimulation

PLACEBO COMPARATOR

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

Device: Fisher Wallace Cranial Stimulator

Interventions

Fisher Wallace Cranial Stimulator DEVICE

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

Active stimulation; Sham stimulation

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• Mending Minds Foundation: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (2)

• 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.

  PMID: 15646771 BACKGROUND

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

  BACKGROUND

Limitations and Caveats

Small number of subjects analyzed.

Results Point of Contact

• Title: Scott E. Lukas, Ph.D.
• Organization: McLean Imaging Center, McLean Hospital

slukas@mclean.harvard.edu

617-855-2767

Study Officials

• Scott E Lukas, PhD

  McLean Imaging Center, McLean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, McLean Imaging Center

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: May 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)