Fisher Wallace Neurostimulation & Depression Study

Last updated: February 9, 2021
Sponsor: ProofPilot
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Affective Disorders

Depression

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT04541563
2518
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 175
Study Start date:
August 24, 2020
Estimated Completion Date:
November 30, 2021

Connect with a study center

  • ProofPilot (Remote Virtual Trial)

    New York, New York 10003
    United States

    Site Not Available

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