Brain Stimulation & Generalized Anxiety Study

February 9, 2021 updated by: ProofPilot

Fisher Wallace 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • ProofPilot (Remote Virtual Trial)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active Arm
Participants receive active device for the full 8 week study
Device: Cranial Electrotherapy Stimulator (CES) Device
Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device
SHAM_COMPARATOR: Sham Arm
Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device.
Device: Cranial Electrotherapy Stimulator (CES) Device
Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Beck Anxiety Inventory (BAI) Score
Time Frame: baseline versus week 4
The Beck is a 21 item self-reported scale measuring anxiety
baseline versus week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Promise Sleep-SD
Time Frame: baseline versus week 4
Change in self reported sleep quality
baseline versus week 4
Change in Patient Health Questionnaire - 8 (PHQ-8)
Time Frame: baseline versus week 4
self reported depression symptoms
baseline versus week 4
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
week 4 versus week 8
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
baseline versus week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProofPilot

Collaborators

Fisher Wallace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2020

Primary Completion (ANTICIPATED)

March 31, 2021

Study Completion (ANTICIPATED)

June 21, 2021

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

February 9, 2021

First Posted (ACTUAL)

February 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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