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Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01325532
First Posted: March 29, 2011
Last Update Posted: June 1, 2016
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:
Fisher Wallace Labs, LLC
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital
Results First Submitted: March 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Device: Active CES
Device: Sham CES

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited by advertisement from our Depression Clinical and Research Program (DCRP). Informed consent was obtained per IRB guidelines. Investigators who screened subjects were our program’s psychiatrists and psychologists, trained and certified in the use of appropriate diagnostic instruments such as the SCID and HAM-D.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who passed the screen visit returned a week later for the baseline visit. At that time, subjects received their first treatment (or sham) at the site for 20 minutes, including personal instruction of proper technique and electrode placement.

Reporting Groups
  Description
Active CES

Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.

Active CES: CES current

Sham CES

Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.

Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.


Participant Flow:   Overall Study
    Active CES   Sham CES
STARTED   17   13 
COMPLETED   15   13 
NOT COMPLETED   2   0 
Withdrawal by Subject                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adults with MDD; the HAM-D score eligibility range was set to include subjects who were partial or non-responders (HAM-D 15-18) but not too severely depressed (HAMD ≤ 23), given CES’s experimental nature.

Reporting Groups
  Description
Active CES

Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.

Active CES: CES current

Sham CES

Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.

Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.

Total Total of all reporting groups

Baseline Measures
   Active CES   Sham CES   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   13   30 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   17   13   30 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.5  (12.3)   51.4  (11.9)   48.1  (12.3) 
Gender 
[Units: Participants]
     
Female   10   7   17 
Male   7   6   13 
Region of Enrollment 
[Units: Participants]
     
United States   17   13   30 
Hamilton Depression Rating Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 18.1  (1.5)   18.7  (3.9)   18.3  (2.8) 
[1] The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3   [ Time Frame: Baseline-Week 3 ]

2.  Primary:   Reported Side Effects Based on PRISE AE Scores   [ Time Frame: Baseline-Week 3 ]

3.  Secondary:   Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3.   [ Time Frame: Baseline-Week 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The main limitations include a small sample and lack of an active comparator. Because CES did not separate from its sham counterpart in this sample of MDD patients, we cannot rule out that the benefit obtained from CES was due to placebo effects.


  More Information
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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: Dr David Mischoulon
Organization: Massachusetts General Hospital, Dept of Psychiatry
phone: 617-724-5198
e-mail: dmischoulon@partners.org


Publications of Results:

Responsible Party: David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01325532     History of Changes
Other Study ID Numbers: 2010 P000461
First Submitted: March 24, 2011
First Posted: March 29, 2011
Results First Submitted: March 20, 2016
Results First Posted: June 1, 2016
Last Update Posted: June 1, 2016