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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01860677
First Posted: May 23, 2013
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mending Minds Foundation
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
  Purpose
Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.

Condition Intervention
Mood Device: Fisher Wallace Cranial Stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood: An fMRI/MRS Study

Further study details as provided by Scott Lukas, Mclean Hospital:

Primary Outcome Measures:
  • BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits [ Time Frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment ]

    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.



Secondary Outcome Measures:
  • BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only [ Time Frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment ]

    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.


  • Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm [ Time Frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment ]

    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.


  • Change in Visual Analogue Scale (VAS) in Active Stimulation Arm [ Time Frame: within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment ]

    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.



Enrollment: 8
Study Start Date: May 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860677


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Mending Minds Foundation
Investigators
Principal Investigator: Scott E Lukas, PhD McLean Imaging Center, McLean Hospital
  More Information

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

Responsible Party: Scott Lukas, Director, McLean Imaging Center, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01860677     History of Changes
Other Study ID Numbers: P-001567
First Submitted: May 20, 2013
First Posted: May 23, 2013
Results First Submitted: October 1, 2014
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Scott Lukas, Mclean Hospital:
cranial stimulation
BOLD (Blood Oxygenation Level Dependent)
fMRI (Functional Magnetic Resonance Imaging)
spectroscopy