Brain Stimulation & Generalized Anxiety Study

Phase 4

Active, not recruiting

• Conditions: Generalized Anxiety Disorder; Anxiety; Generalized Anxiety
• Interventions: Device: Cranial Electrotherapy Stimulator (CES) Device

• Registration Number: NCT04751864
• Lead Sponsor: ProofPilot

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2020-11-09
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Study First Posted: 2021-02-12
• Last Update Posted: 2021-02-12
• Primary Completion: 2021-03-31
• Study Completion: 2021-06-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Arm	Cranial Electrotherapy Stimulator (CES) Device	Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device.
Active Arm	Cranial Electrotherapy Stimulator (CES) Device	Participants receive active device for the full 8 week study

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Change in Promise Sleep-SD	baseline versus week 4	Change in self reported sleep quality
Change in Beck Anxiety Inventory (BAI) Score	week 4 versus week 8	The Beck is a 21 item self-reported scale measuring anxiety
Change in Patient Health Questionnaire - 8 (PHQ-8)	baseline versus week 4	self reported depression symptoms

Trial Locations

Locations (1)

ProofPilot (Remote Virtual Trial); 🇺🇸 New York, New York, United States