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NCT04541563Active, not recruiting

Fisher Wallace Neurostimulation & Depression Study

Neurostimulation & Depression Study

Source: ClinicalTrials.gov · Last updated 11 Feb 2021

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
175 (estimated)
First submitted
14 Aug 2020
Start date
24 Aug 2020
Primary completion date
30 Mar 2021
Lead sponsor
ProofPilot
Diseases
Depression
NCT number
NCT04541563

What you commit to

  • Study type: Interventional
  • Planned participants: 175
  • From 24 Aug 2020 to the primary completion date, 30 Mar 2021
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 21 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ProofPilot (Remote Virtual Trial)
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.