Status:
ACTIVE_NOT_RECRUITING
Brain Stimulation & Generalized Anxiety Study
Lead Sponsor:
ProofPilot
Collaborating Sponsors:
Fisher Wallace
Conditions:
Anxiety
Generalized Anxiety Disorder
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 21 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04751864
Start Date
October 15 2020
End Date
June 21 2021
Last Update
February 12 2021
Active Locations (1)
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1
ProofPilot (Remote Virtual Trial)
New York, New York, United States, 10003