Brain Stimulation & Generalized Anxiety Study

• Sponsor: ProofPilot (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04751864
• Collaborator: Fisher Wallace (Other)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.2
• Patients Per Site Per Month: 18.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Generalized Anxiety Disorder; Generalized Anxiety	Device: Cranial Electrotherapy Stimulator (CES) Device	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.Participants randomized into Sham and Active device arms for four weeks. At the week 5 crossover, participants in sham arm receive active device.
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Fisher Wallace Brain Stimulation & Generalized Anxiety Study
• Actual Study Start Date: Oct 15, 2020
• Anticipated Primary Completion Date: Mar 31, 2021
• Anticipated Study Completion Date: Jun 21, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Beck Anxiety Inventory (BAI) Score [baseline versus week 4]

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

Secondary Outcome Measures

1. Change in Promise Sleep-SD [baseline versus week 4]

   Change in self reported sleep quality

2. Change in Patient Health Questionnaire - 8 (PHQ-8) [baseline versus week 4]

   self reported depression symptoms

3. Change in Beck Anxiety Inventory (BAI) Score [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 [baseline versus week 8]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProofPilot (Remote Virtual Trial)	New York	New York	United States	10003

Sponsors and Collaborators

• ProofPilot
• Fisher Wallace

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ProofPilot
• ClinicalTrials.gov Identifier: NCT04751864
• Other Study ID Numbers: 2503
• First Posted: Feb 12, 2021
• Last Update Posted: Feb 12, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Feb 12, 2021