Brain Stimulation & Generalized Anxiety Study

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: Generalized Anxiety Disorder; Anxiety; Generalized Anxiety
• Intervention / Treatment: Device: Cranial Electrotherapy Stimulator (CES) Device

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Change in self reported sleep quality	baseline versus week 4
Change in Patient Health Questionnaire - 8 (PHQ-8)	self reported depression symptoms	baseline versus week 4
Change in Beck Anxiety Inventory (BAI) Score	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	The SAFTEE is a self reported measure of side effects associated with mental health treatments	baseline versus week 8

Collaborators and Investigators

• Sponsor: ProofPilot
• Collaborators: Fisher Wallace

Study record dates

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: Mental Disorders; Anxiety Disorders
• 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