Brain Stimulation & Generalized Anxiety Study

Anxiety Clinical Trial

Official title:

Fisher Wallace Brain Stimulation & Generalized Anxiety Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04751864
• Other study ID #: 2503
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 15, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: February 2021
• Source: ProofPilot
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 21, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Generalized Anxiety
• Generalized Anxiety Disorder

Intervention

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

Locations

Country	Name	City	State
United States	ProofPilot (Remote Virtual Trial)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
ProofPilot	Fisher Wallace

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Beck Anxiety Inventory (BAI) Score	The Beck is a 21 item self-reported scale measuring anxiety	baseline versus week 4
Secondary	Change in Promise Sleep-SD	Change in self reported sleep quality	baseline versus week 4
Secondary	Change in Patient Health Questionnaire - 8 (PHQ-8)	self reported depression symptoms	baseline versus week 4
Secondary	Change in Beck Anxiety Inventory (BAI) Score	The Beck is a 21 item self-reported scale measuring anxiety	week 4 versus week 8
Secondary	Device safety, tolerability and adherence as measured by SAFTEE	The SAFTEE is a self reported measure of side effects associated with mental health treatments	baseline versus week 8