The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood
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 |
---|---|---|
|
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
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
- 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
- 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.
- 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.
- 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
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
- 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.
- Smith RB (2006) Cranial electrotherapy stimulation: Its first fifty years, plus three: a monograph. Oklahoma: Tate Publishing & Enterprises
- P-001567
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
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 |
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)
|
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)
|
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
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 |
slukas@mclean.harvard.edu |
- P-001567