If depression symptoms stop, the device is then used two or three times a week to maintain improvement. The device is used twice a day for at least 30 days. The device stimulates the brain with gentle electrical impulses in 20-minute sessions. The Fisher Wallace Stimulator is a small, handheld, battery-powered device that connects to a headset. As soon as a change is implemented on, this will be updated automatically on our website as well.The Fisher Wallace Stimulator is a device cleared by the FDA to treat depression, anxiety, insomnia, and chronic pain.
#Fisher wallace stimulator update
If you have any requests to change, remove or update your study details, please contact. This information was retrieved directly from the website without any changes. Participants will be unblinded at week 4 at the crossover. Participants will be randomized in ProofPilot, and only the fulfillment center will know whether the participant is in the placebo or control arm. Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
#Fisher wallace stimulator full
The participant will remain with the active device for the full 8 weeks.
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. Participants will be randomized into an immediate or delayed treatment arm. 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.
#Fisher wallace stimulator trial
This is a fully remote trial where participants engage at home in the study using the ProofPilot study platform. The delayed arm participants will continue with active devices for the remaining 4 weeks of the trial. 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). In the delayed treatment arm, the participants will receive a sham device that looks exactly the same, but only provides treatment for 2 seconds. 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 professionalsĬontact information is only displayed when the study is recruiting subjects. 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.
Intervention Name: Fisher Wallace Cranial Electrotherapy Stimulator Deviceįisher Wallace Stimulator®, a patented cranial electrotherapy stimulation device that was cleared by the FDA in 1991 for the treatment of depression, anxiety and insomnia.
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