Brain Stimulation & Generalized Anxiety Study

NCT04751864 | Active Not Recruiting Phase 4 FDA Device

• 1 other identifier: 2503
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Generalized Anxiety Disorder; Generalized Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Beck Anxiety Inventory (BAI) Score

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

  baseline versus week 4

Secondary Outcomes (4)

• Change in Promise Sleep-SD

  baseline versus week 4

• Change in Patient Health Questionnaire - 8 (PHQ-8)

  baseline versus week 4

• Change in Beck Anxiety Inventory (BAI) Score

  week 4 versus week 8

• Device safety, tolerability and adherence as measured by SAFTEE

  baseline versus week 8

Study Arms (2)

Active Arm

EXPERIMENTAL

Participants receive active device for the full 8 week study

Device: Cranial Electrotherapy Stimulator (CES) Device

Sham Arm

SHAM COMPARATOR

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

Interventions

Cranial Electrotherapy Stimulator (CES) Device DEVICE

Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device

Active Arm; Sham Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• ProofPilot: lead
• Fisher Wallace: collaborator

Study Sites (1)

ProofPilot (Remote Virtual Trial)

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants randomized into Sham and Active device arms for four weeks. At the week 5 crossover, participants in sham arm receive active device.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: February 12, 2021
• Study Start: October 15, 2020
• Primary Completion: March 31, 2021
• Study Completion: June 21, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)