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

The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood: An fMRI/MRS Study

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

Study Overview

• Status: Completed
• Conditions: Mood
• Intervention / Treatment: Device: Fisher Wallace Cranial Stimulator

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Fisher Wallace Cranial Stimulator; The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
Placebo Comparator: 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.	Device: Fisher Wallace Cranial Stimulator; The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only	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
Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm	Positive and Negative Affect Schedule (PANAS), as defined by Watson et al. (1988), range between 10 and 50 points. Anchors of "not at all" (10) to "most ever" (50) were used to rank each measure. Change compares post-treatment to pre-treatment. Positive Affects included the following terms: Attentive, Active, Alert, Excited, Enthusiastic, Determined, Inspired, Proud, Interested, and Strong. Negative Affects included the following terms: Hostile, Irritable, Ashamed, Guilty, Distressed, Upset, Scared, Afraid, Jittery, and Nervous. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome.	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	Visual Analogue Scale (VAS) ranges from 0-100. Anchors of "not at all" (0) to "most ever" (100) were used to rank the following: anxious, sleepy, dizzy, relaxed, physical symptoms, confused, sluggish, energetic, fatigued, and stressed. Change compares post-treatment to pre-treatment.	within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: Mending Minds Foundation
• Investigators: Principal Investigator: Scott E Lukas, PhD, McLean Imaging Center, McLean Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 20, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: spectroscopy; cranial stimulation; BOLD (Blood Oxygenation Level Dependent); fMRI (Functional Magnetic Resonance Imaging)
• Other Study ID Numbers: P-001567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No