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Fisher Wallace Neurostimulation & Depression Study

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.
 
ClinicalTrials.gov Identifier: NCT04541563
Recruitment Status : Active, not recruiting
First Posted : September 9, 2020
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
Fisher Wallace
Information provided by (Responsible Party):
ProofPilot

Brief Summary:
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device on Major Depressive Disorder using two 20-minute per day treatment sessions over eight weeks.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Fisher Wallace Cranial Electrotherapy Stimulator Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

This is a fully remote trial where participants engage at home in the study using the ProofPilot study platform. All potential participant enrollment data, including proof of identity via government ID will be reviewed by licensed medical professionals in the participant's state prior to their full enrollment.

Participants will be randomized into an immediate or delayed treatment arm. The immediate treatment arm participants will be shipped an active Fisher Wallace device limited to Level 2 output even if a participant raises the dial beyond that. The participant will remain with the active device for the full 8 weeks.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

This is a fully remote trial. Participants will be randomized in ProofPilot, and only the fulfillment center will know whether the participant is in the placebo or control arm.

Participants will be unblinded at week 4 at the crossover.

Primary Purpose: Treatment
Official Title: Neurostimulation & Depression Study
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Treatment Arm
The immediate treatment arm participants will be shipped an active Fisher Wallace device limited to Level 2 output even if a participant raises the dial beyond that. The participant will remain with the active device for the full 8 weeks.
Device: Fisher Wallace Cranial Electrotherapy Stimulator Device
Fisher Wallace Stimulator®, a patented cranial electrotherapy stimulation device that was cleared by the FDA in 1991 for the treatment of depression, anxiety and insomnia.

Sham Comparator: Delayed Treatment Arm
In the delayed treatment arm, the participants will receive a sham device that looks exactly the same, but only provides treatment for 2 seconds. At week 4, sham arm participants will be unblinded and shipped an active device (limited to Level 2 output even if a participant raises the dial beyond that). The delayed arm participants will continue with active devices for the remaining 4 weeks of the trial.
Device: Fisher Wallace Cranial Electrotherapy Stimulator Device
Fisher Wallace Stimulator®, a patented cranial electrotherapy stimulation device that was cleared by the FDA in 1991 for the treatment of depression, anxiety and insomnia.




Primary Outcome Measures :
  1. Change in Beck Depression Inventory Score Baseline vs week 4 [ Time Frame: Week 4 ]
    Change in depression symptoms from baseline to treatment week 4 in immediate versus delayed arm. Lower scores show improvement in depression symptoms.


Secondary Outcome Measures :
  1. Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8 [ Time Frame: Week 8 ]
    assessment at week tolerability, safety and adherence at week 8

  2. Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4 [ Time Frame: Week 4 ]
    Change in self reported depression self assessed at baseline and week 4. Lower scores in the PHQ-8 show improvement in depression symptoms

  3. Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2 [ Time Frame: Week 2 ]
    Change in self reported depression self assessed at baseline and week 2. Lower scores in the PHQ-8 show improvement in depression symptoms.

  4. Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8 [ Time Frame: Week 8 ]
    Participants will self assess at point of receiving active device at crossover for the remaining 4 weeks of the trial. Lower scores show improvement in depression symptoms.

  5. Change in Hamilton Depression Score Baseline vs week 4 [ Time Frame: Week 4 ]
    Participants will be assessed by a tele-psychiatrist at baseline and week 4. Lower scores show improvement in depression symptoms.

  6. Change in Hamilton Depression Score Baseline vs week 2 [ Time Frame: Week 2 ]
    Participants will be assessed by a tele-psychiatrist at baseline and week 2. Lower scores show improvement in depression symptoms.



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.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Age greater than or equal to 21
  • US resident
  • Can receive packages to their home via UPS/Fedex/USPS
  • Major Depressive Disorder
  • PHQ-8 Score greater than 10 (show some signs of mild to moderate depression)
  • PHQ-8 Score less than 20 (given remote study serious depressed should be excluded)
  • Read/write English
  • have not contemplated suicide in the past year
  • not been institutionalized for mental health issues.
  • not currently experiencing problems with alcohol or drug abuse
  • can commit to not drinking alcohol 4 hours before bedtime for the duration of the study
  • can commit to two (2) 20 minute sessions per day for 8 weeks
  • has not used a brain stimulation treatment in one year
  • no suspected or known history of heart disease
  • no pacemaker
  • not under medical supervision for other serious medical condition
  • not taking opioids
  • is a resident of states in which we have licensed medical professionals

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): NCT04541563


Locations
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United States, New York
ProofPilot (Remote Virtual Trial)
New York, New York, United States, 10003
Sponsors and Collaborators
ProofPilot
Fisher Wallace
  Study Documents (Full-Text)

Documents provided by ProofPilot:
Study Protocol  [PDF] August 16, 2020
Informed Consent Form  [PDF] August 9, 2020

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Responsible Party: ProofPilot
ClinicalTrials.gov Identifier: NCT04541563    
Other Study ID Numbers: 2518
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders