Fisher Wallace Neurostimulation & Depression Study

ProofPilot

Status: Active, not recruiting

Conditions: Major Depressive Disorder

Treatments: Device: Fisher Wallace Cranial Electrotherapy Stimulator Device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04541563

2518

Details and patient eligibility

About

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.

Enrollment: 175 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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175 participants in 2 patient groups

Immediate Treatment Arm

Experimental group

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.

Treatment:

Device: Fisher Wallace Cranial Electrotherapy Stimulator Device

Delayed Treatment Arm

Sham Comparator group

Description:

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.

Treatment:

Device: Fisher Wallace Cranial Electrotherapy Stimulator Device