Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2020-10-15
2021-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Active Arm
Participants receive active device for the full 8 week study
Cranial Electrotherapy Stimulator (CES) Device
Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device
Sham Arm
Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device.
Cranial Electrotherapy Stimulator (CES) Device
Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device
Interventions
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Cranial Electrotherapy Stimulator (CES) Device
Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device
Eligibility Criteria
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Inclusion Criteria
* 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)
21 Years
ALL
Yes
Sponsors
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Fisher Wallace
UNKNOWN
ProofPilot
INDUSTRY
Responsible Party
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Locations
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ProofPilot (Remote Virtual Trial)
New York, New York, United States
Countries
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Other Identifiers
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2503
Identifier Type: -
Identifier Source: org_study_id
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