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Clinical Trials in the USA / NCT04751864
Active, not recruiting Phase 4

Brain Stimulation & Generalized Anxiety Study

NCT04751864 · tracked via the Priya Life Science USA tracker
Sponsor
ProofPilot
Phase
Phase 4
Started
2020-10-15
Last updated
2021-02-12

Condition(s) studied

AnxietyGeneralized Anxiety DisorderGeneralized Anxiety

Investigational drug(s) / intervention(s)

Cranial Electrotherapy Stimulator (CES) Device

Cranial Electrotherapy Stimulator (CES) Device: Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
ProofPilot (Remote Virtual Trial) New York New York

More ProofPilot trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04751864 on ClinicalTrials.gov ↗ ← All trials in the USA