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Fisher Wallace Neurostimulation & Depression Study

Primary Purpose

Major Depressive Disorder

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fisher Wallace Cranial Electrotherapy Stimulator Device

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

ProofPilot (Remote Virtual Trial)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Immediate Treatment Arm

Delayed Treatment Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Beck Depression Inventory Score Baseline vs 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

assessment at week tolerability, safety and adherence at week 8

Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs 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

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

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

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

Participants will be assessed by a tele-psychiatrist at baseline and week 2. Lower scores show improvement in depression symptoms.

Full Information

NCT ID

NCT04541563

First Posted

August 14, 2020

Last Updated

February 9, 2021

Sponsor

ProofPilot

Collaborators

Fisher Wallace

1. Study Identification

Unique Protocol Identification Number

NCT04541563

Brief Title

Fisher Wallace Neurostimulation & Depression Study

Official Title

Neurostimulation & Depression Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 24, 2020 (Actual)

Primary Completion Date

March 30, 2021 (Anticipated)

Study Completion Date

November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ProofPilot

Collaborators

Fisher Wallace

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immediate Treatment Arm

Arm Type

Experimental

Arm Description

Arm Title

Delayed Treatment Arm

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Fisher Wallace Cranial Electrotherapy Stimulator Device

Intervention Description

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 Measure Information:

Title

Change in Beck Depression Inventory Score Baseline vs week 4

Description

Change in depression symptoms from baseline to treatment week 4 in immediate versus delayed arm. Lower scores show improvement in depression symptoms.

Time Frame

Week 4

Secondary Outcome Measure Information:

Title

Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8

Description

assessment at week tolerability, safety and adherence at week 8

Time Frame

Week 8

Title

Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4

Description

Change in self reported depression self assessed at baseline and week 4. Lower scores in the PHQ-8 show improvement in depression symptoms

Time Frame

Week 4

Title

Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2

Description

Change in self reported depression self assessed at baseline and week 2. Lower scores in the PHQ-8 show improvement in depression symptoms.

Time Frame

Week 2

Title

Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8

Description

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.

Time Frame

Week 8

Title

Change in Hamilton Depression Score Baseline vs week 4

Description

Participants will be assessed by a tele-psychiatrist at baseline and week 4. Lower scores show improvement in depression symptoms.

Time Frame

Week 4

Title

Change in Hamilton Depression Score Baseline vs week 2

Description

Participants will be assessed by a tele-psychiatrist at baseline and week 2. Lower scores show improvement in depression symptoms.

Time Frame

Week 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

ProofPilot (Remote Virtual Trial)

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Fisher Wallace Neurostimulation & Depression Study

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