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Brain Stimulation & Generalized Anxiety Study

Primary Purpose

Anxiety, Generalized Anxiety Disorder, Generalized Anxiety

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cranial Electrotherapy Stimulator (CES) Device
Sponsored by
ProofPilot
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • ProofPilot (Remote Virtual Trial)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Arm

Sham Arm

Arm Description

Participants receive active device for the full 8 week study

Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device.

Outcomes

Primary Outcome Measures

Change in Beck Anxiety Inventory (BAI) Score
The Beck is a 21 item self-reported scale measuring anxiety

Secondary Outcome Measures

Change in Promise Sleep-SD
Change in self reported sleep quality
Change in Patient Health Questionnaire - 8 (PHQ-8)
self reported depression symptoms
Change in Beck Anxiety Inventory (BAI) Score
The Beck is a 21 item self-reported scale measuring anxiety
Device safety, tolerability and adherence as measured by SAFTEE
The SAFTEE is a self reported measure of side effects associated with mental health treatments

Full Information

First Posted
November 9, 2020
Last Updated
February 9, 2021
Sponsor
ProofPilot
Collaborators
Fisher Wallace
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1. Study Identification

Unique Protocol Identification Number
NCT04751864
Brief Title
Brain Stimulation & Generalized Anxiety Study
Official Title
Fisher Wallace Brain Stimulation & Generalized Anxiety Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
June 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProofPilot
Collaborators
Fisher Wallace

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Generalized Anxiety Disorder, Generalized Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Participants randomized into Sham and Active device arms for four weeks. At the week 5 crossover, participants in sham arm receive active device.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Arm
Arm Type
Experimental
Arm Description
Participants receive active device for the full 8 week study
Arm Title
Sham Arm
Arm Type
Sham Comparator
Arm Description
Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device.
Intervention Type
Device
Intervention Name(s)
Cranial Electrotherapy Stimulator (CES) Device
Intervention Description
Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device
Primary Outcome Measure Information:
Title
Change in Beck Anxiety Inventory (BAI) Score
Description
The Beck is a 21 item self-reported scale measuring anxiety
Time Frame
baseline versus week 4
Secondary Outcome Measure Information:
Title
Change in Promise Sleep-SD
Description
Change in self reported sleep quality
Time Frame
baseline versus week 4
Title
Change in Patient Health Questionnaire - 8 (PHQ-8)
Description
self reported depression symptoms
Time Frame
baseline versus week 4
Title
Change in Beck Anxiety Inventory (BAI) Score
Description
The Beck is a 21 item self-reported scale measuring anxiety
Time Frame
week 4 versus week 8
Title
Device safety, tolerability and adherence as measured by SAFTEE
Description
The SAFTEE is a self reported measure of side effects associated with mental health treatments
Time Frame
baseline versus week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
ProofPilot (Remote Virtual Trial)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Brain Stimulation & Generalized Anxiety Study

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