Fisher Wallace Neurostimulation & Depression Study

Neurostimulation & Depression Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: Fisher Wallace Cranial Electrotherapy Stimulator Device

• Study Type: Interventional
• Enrollment (Anticipated): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • ProofPilot (Remote Virtual Trial)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8	assessment at week tolerability, safety and adherence at week 8	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	Week 4
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.	Week 2
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.	Week 8
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.	Week 4
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.	Week 2

Collaborators and Investigators

• Sponsor: ProofPilot
• Collaborators: Fisher Wallace

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• 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