Fisher Wallace Neurostimulation & Depression Study

Study Overview
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Brief Summary
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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.

Official Title
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Neurostimulation & Depression Study

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Fisher Wallace Cranial Electrotherapy Stimulator Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment Arm<br>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<br>* 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.<br>|
| Sham Comparator: Delayed Treatment Arm<br>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<br>* 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.<br>|

What is the study measuring?
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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 |