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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04751864
Other study ID # 2503
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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)

Study Design


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
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