Brain Stimulation & Generalized Anxiety Study

ProofPilot

Status and phase: Active, not recruiting; Phase 4

Conditions: Generalized Anxiety Disorder; Anxiety; Generalized Anxiety

Treatments: Device: Cranial Electrotherapy Stimulator (CES) Device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04751864

2503

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Active Arm

Experimental group

Description:

Participants receive active device for the full 8 week study

Treatment:

Device: Cranial Electrotherapy Stimulator (CES) Device

Sham Arm

Sham Comparator group

Description:

Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device.

Treatment:

Device: Cranial Electrotherapy Stimulator (CES) Device