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OpenTrials
Active, Not Recruiting

NCT Number: NCT04751864

Brain Stimulation & Generalized Anxiety Study

Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device on Generalized Anxiety Disorder using two (2) 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

Anxiety Anxiety Disorders Generalized Anxiety Generalized Anxiety Disorder Mental Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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 21
  • US resident
  • Can receive packages to their home via UPS/Fedex/USPS
  • Licensed Physician Diagnosis of Generalized Anxiety Disorder
  • Beck Anxiety Inventory Score between 8 and 25
  • 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
  • Not under medical supervision for serious medical condition
  • Not currently being treated for or suspect a mental health issue
  • Has not used a brain stimulation treatment in one year
  • No suspected or known history of heart disease
  • No pacemaker, or any form of medical electronics, including but not limited to a deep - brain stimulator, electronic stent, etc.
  • Not taking opioids
  • Are a resident of states in which we have licensed medical professionals
  • Does not have any co-occurring significant psychiatric disorder that would impair - participant's particationion.
  • Does not use any illicit drugs
  • Not participating in any other anxiety study
  • Not taking medications affecting the nervous system (e.g. psychiatric medications)
  • Not taking hypnotics or any sleep aid or marijuana (in any form)

Treatment and study plan

Cranial Electrotherapy Stimulator (CES) Device

Device

Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device

Primary outcomes

  1. Change in Beck Anxiety Inventory (BAI) Score

    Time frame: baseline versus week 4

    The Beck is a 21 item self-reported scale measuring anxiety

Secondary outcomes

  1. Change in Promise Sleep-SD

    Time frame: baseline versus week 4

    Change in self reported sleep quality

  2. Change in Patient Health Questionnaire - 8 (PHQ-8)

    Time frame: baseline versus week 4

    self reported depression symptoms

  3. Change in Beck Anxiety Inventory (BAI) Score

    Time frame: week 4 versus week 8

    The Beck is a 21 item self-reported scale measuring anxiety

  4. Device safety, tolerability and adherence as measured by SAFTEE

    Time frame: baseline versus week 8

    The SAFTEE is a self reported measure of side effects associated with mental health treatments

Sponsors and collaborators

Lead sponsor

ProofPilot

Industry

Collaborators

  • Fisher Wallace

Registry information

Official study title

Fisher Wallace Brain Stimulation & Generalized Anxiety Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2021
Registry last updated
Feb 12, 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.

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