Brain Stimulation & Generalized Anxiety Study

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Anxiety, Generalized Anxiety Disorder, Generalized Anxiety

In brief

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.

Key facts

Study ID

NCT04751864

Run by

ProofPilot

People needed

150

Starts

2020-10-15

Expected to finish

2021-06-21

Last updated by the study team

2021-02-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

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
• 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)

Where it is running

• ProofPilot (Remote Virtual Trial) — New York, New York, United States

Full record on ClinicalTrials.gov

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