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

Sponsor
Mclean Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01860677
Collaborator
Mending Minds Foundation (Other)
8
1
2
49
0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Fisher Wallace Cranial Stimulator
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
8 participants
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
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

  1. 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]

    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.

  2. 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]

    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.

  3. 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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Scott Lukas, Director, McLean Imaging Center, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01860677
Other Study ID Numbers:
  • P-001567
First Posted:
May 23, 2013
Last Update Posted:
Jun 14, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Scott Lukas, Director, McLean Imaging Center, Mclean Hospital

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Active First, Then Sham Sham First, Then Active
Arm/Group Description Active treatment first, then Sham Active: The Fisher Wallace Cranial Electrostimulation 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. Fisher Wallace Cranial Stimulator Sham: Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. Sham first, then Active treatment Active: The Fisher Wallace Cranial Electrostimulation 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. Fisher Wallace Cranial Stimulator Sham: Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
Period Title: First Intervention (1 Day)
STARTED 8 0
COMPLETED 8 0
NOT COMPLETED 0 0
Period Title: First Intervention (1 Day)
STARTED 8 0
COMPLETED 1 0
NOT COMPLETED 7 0

Baseline Characteristics

Arm/Group Title All Study Participants
Arm/Group Description All of the study participants
Overall Participants 8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
25.4
(4.5)
Sex: Female, Male (Count of Participants)
Female
5
62.5%
Male
3
37.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
Not Hispanic or Latino
8
100%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
4
50%
White
4
50%
More than one race
0
0%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
United States
8
100%
Caffeine consumption (caffeinated beverages/week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [caffeinated beverages/week]
5.2
(6.1)
Alcohol consumption (alcoolic drinks/week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [alcoolic drinks/week]
2.1
(2.1)
Marihuana use (spelling with 'h' used by DEA and FDA) (lifetime uses) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lifetime uses]
3.5
(6.9)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
24.35
(4.76)

Outcome Measures

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

Outcome Measure Data

Analysis Population Description
Data were not collected
Arm/Group Title Active Stimulation Sham Stimulation
Arm/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. Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
Measure Participants 0 0
2. Secondary Outcome
Title BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only
Description 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.
Time Frame within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment

Outcome Measure Data

Analysis Population Description
Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only
Arm/Group Title Active Stimulation
Arm/Group Description The Fisher Wallace Cranial Electrostimulation 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. Fisher Wallace Cranial Stimulator
Measure Participants 8
Mean (Standard Deviation) [coupling ratio]
0.2
(0.5)
3. Secondary Outcome
Title Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm
Description 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.
Time Frame within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment

Outcome Measure Data

Analysis Population Description
Participants in the active stimulation arm. Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.
Arm/Group Title Active Stimulation
Arm/Group Description The Fisher Wallace Cranial Electrostimulation 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. Fisher Wallace Cranial Stimulator
Measure Participants 8
PANAS Positive Affect
1.88
(3.60)
PANAS Negative Affect
-0.63
(0.74)
4. Secondary Outcome
Title Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Description 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.
Time Frame within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment

Outcome Measure Data

Analysis Population Description
Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only. 3 participants were missing data on these measures.
Arm/Group Title Active Stimulation
Arm/Group Description The Fisher Wallace Cranial Electrostimulation 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. Fisher Wallace Cranial Stimulator
Measure Participants 5
Anxiety
-2.90
(5.85)
Sleepy
5.80
(21.06)
Dizzy
1.10
(6.42)
Relaxed
-2.60
(12.77)
Physical symptoms
2.30
(2.71)
Confused
0.80
(1.89)
Sluggish
-1.80
(18.70)
Energetic
0.00
(9.56)
Fatigued
3.80
(6.52)
Stressed
-3.40
(5.67)

Adverse Events

Time Frame
Adverse Event Reporting Description Only one participant completed the Sham intervention.
Arm/Group Title Active Stimulation Sham Stimulation
Arm/Group Description The Fisher Wallace Cranial Electrostimulation 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. Fisher Wallace Cranial Stimulator Participants are outfitted with a device that is identical in appearance but does not deliver any current.
All Cause Mortality
Active Stimulation Sham Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Active Stimulation Sham Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/8 (0%) 0/1 (0%)
Other (Not Including Serious) Adverse Events
Active Stimulation Sham Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/8 (0%) 0/1 (0%)

Limitations/Caveats

Small number of subjects analyzed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Scott E. Lukas, Ph.D.
Organization McLean Imaging Center, McLean Hospital
Phone 617-855-2767
Email slukas@mclean.harvard.edu
Responsible Party:
Scott Lukas, Director, McLean Imaging Center, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01860677
Other Study ID Numbers:
  • P-001567
First Posted:
May 23, 2013
Last Update Posted:
Jun 14, 2017
Last Verified:
May 1, 2017