Trial Outcomes & Findings for The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood (NCT NCT01860677)
NCT ID: NCT01860677
Last Updated: 2017-06-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Active First, Then Sham
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
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.
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
8
|
0
|
|
First Intervention (1 Day)
COMPLETED
|
8
|
0
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
8
|
0
|
|
Second Intervention (1 Day)
COMPLETED
|
1
|
0
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
Active First, Then Sham
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
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.
|
|---|---|---|
|
Second Intervention (1 Day)
Lost to Follow-up
|
7
|
0
|
Baseline Characteristics
The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood
Baseline characteristics by cohort
| Measure |
All Study Participants
n=8 Participants
All of the study participants
|
|---|---|
|
Age, Continuous
|
25.4 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
|
Caffeine consumption
|
5.2 caffeinated beverages/week
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Alcohol consumption
|
2.1 alcoolic drinks/week
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Marihuana use (spelling with 'h' used by DEA and FDA)
|
3.5 lifetime uses
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Body Mass Index (BMI)
|
24.35 kg/m^2
STANDARD_DEVIATION 4.76 • n=5 Participants
|
PRIMARY outcome
Timeframe: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatmentPopulation: Data were not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatmentPopulation: Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active 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.
Outcome measures
| Measure |
Active Stimulation
n=8 Participants
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.
|
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.
Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
|
|---|---|---|
|
BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only
|
0.2 coupling ratio
Standard Deviation 0.5
|
—
|
SECONDARY outcome
Timeframe: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatmentPopulation: Participants in the active stimulation arm. Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.
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.
Outcome measures
| Measure |
Active Stimulation
n=8 Participants
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.
|
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.
Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
|
|---|---|---|
|
Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm
PANAS Positive Affect
|
1.88 units on a scale
Standard Deviation 3.60
|
—
|
|
Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm
PANAS Negative Affect
|
-0.63 units on a scale
Standard Deviation 0.74
|
—
|
SECONDARY outcome
Timeframe: within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Active Stimulation
n=5 Participants
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.
|
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.
Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
|
|---|---|---|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Anxiety
|
-2.90 units on a scale
Standard Deviation 5.85
|
—
|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Sleepy
|
5.80 units on a scale
Standard Deviation 21.06
|
—
|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Dizzy
|
1.10 units on a scale
Standard Deviation 6.42
|
—
|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Relaxed
|
-2.60 units on a scale
Standard Deviation 12.77
|
—
|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Physical symptoms
|
2.30 units on a scale
Standard Deviation 2.71
|
—
|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Confused
|
0.80 units on a scale
Standard Deviation 1.89
|
—
|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Sluggish
|
-1.80 units on a scale
Standard Deviation 18.70
|
—
|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Energetic
|
0.00 units on a scale
Standard Deviation 9.56
|
—
|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Fatigued
|
3.80 units on a scale
Standard Deviation 6.52
|
—
|
|
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Stressed
|
-3.40 units on a scale
Standard Deviation 5.67
|
—
|
Adverse Events
Active Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Scott E. Lukas, Ph.D.
McLean Imaging Center, McLean Hospital
Phone: 617-855-2767
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place