Fisher Wallace Neurostimulation & Depression Study

Sponsor

ProofPilot (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04541563

Collaborator

Fisher Wallace (Other)

175

Enrollment

Location

Arms

15.2

Anticipated Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Aug 24, 2020

Anticipated Primary Completion Date :

Mar 30, 2021

Anticipated Study Completion Date :

Nov 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Beck Depression Inventory Score Baseline vs week 4 [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

Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8 [Week 8]
assessment at week tolerability, safety and adherence at week 8
Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4 [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
Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2 [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.
Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8 [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.
Change in Hamilton Depression Score Baseline vs week 4 [Week 4]
Participants will be assessed by a tele-psychiatrist at baseline and week 4. Lower scores show improvement in depression symptoms.
Change in Hamilton Depression Score Baseline vs week 2 [Week 2]
Participants will be assessed by a tele-psychiatrist at baseline and week 2. Lower scores show improvement in depression symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProofPilot (Remote Virtual Trial)	New York	New York	United States	10003

Sponsors and Collaborators

ProofPilot
Fisher Wallace

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

ProofPilot

ClinicalTrials.gov Identifier:

NCT04541563

Other Study ID Numbers:

2518

First Posted:

Sep 9, 2020

Last Update Posted:

Feb 11, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Depressive Disorder

Depressive Disorder, Major

Study Results

No Results Posted as of Feb 11, 2021