Fisher Wallace Neurostimulation & Depression Study

NCT04541563 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2518
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  Week 8

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

  Week 4

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

  Week 2

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

  Week 8

• Change in Hamilton Depression Score Baseline vs week 4

  Week 4

Study Arms (2)

Immediate Treatment Arm

EXPERIMENTAL

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

Delayed Treatment Arm

SHAM COMPARATOR

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

Interventions

Fisher Wallace Cranial Electrotherapy Stimulator Device 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.

Delayed Treatment Arm; Immediate Treatment Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• ProofPilot: lead
• Fisher Wallace: collaborator

Study Sites (1)

ProofPilot (Remote Virtual Trial)

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: September 9, 2020
• Study Start: August 24, 2020
• Primary Completion: March 30, 2021
• Study Completion: November 30, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)