Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04541563

Fisher Wallace Neurostimulation & Depression Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ProofPilot (Remote Virtual Trial)

New York, 10003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fisher Wallace Cranial Electrotherapy Stimulator Device

Device

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.

Primary outcomes

  1. Change in Beck Depression Inventory Score Baseline vs week 4

    Time frame: Week 4

    Change in depression symptoms from baseline to treatment week 4 in immediate versus delayed arm. Lower scores show improvement in depression symptoms.

Secondary outcomes

  1. Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8

    Time frame: Week 8

    assessment at week tolerability, safety and adherence at week 8

  2. Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4

    Time frame: 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

  3. Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2

    Time frame: 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.

  4. Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8

    Time frame: 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.

  5. Change in Hamilton Depression Score Baseline vs week 4

    Time frame: Week 4

    Participants will be assessed by a tele-psychiatrist at baseline and week 4. Lower scores show improvement in depression symptoms.

  6. Change in Hamilton Depression Score Baseline vs week 2

    Time frame: Week 2

    Participants will be assessed by a tele-psychiatrist at baseline and week 2. Lower scores show improvement in depression symptoms.

Sponsors and collaborators

Lead sponsor

ProofPilot

Industry

Collaborators

  • Fisher Wallace

Registry information

Official study title

Neurostimulation & Depression Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.