Brain Stimulation & Generalized Anxiety Study

Study Overview
=================
Brief 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.

Official Title
-----------------
Fisher Wallace Brain Stimulation & Generalized Anxiety Study

Conditions
-----------------
Anxiety, Generalized Anxiety Disorder, Generalized Anxiety

Intervention / Treatment
-----------------
* Device: Cranial Electrotherapy Stimulator (CES) Device


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants randomized into Sham and Active device arms for four weeks. At the week 5 crossover, participants in sham arm receive active device.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Arm<br>Participants receive active device for the full 8 week study | Device: Cranial Electrotherapy Stimulator (CES) Device<br>* Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device<br>|
| Sham Comparator: Sham Arm<br>Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device. | Device: Cranial Electrotherapy Stimulator (CES) Device<br>* Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beck Anxiety Inventory (BAI) Score | The Beck is a 21 item self-reported scale measuring anxiety | baseline versus week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Promise Sleep-SD | Change in self reported sleep quality | baseline versus week 4 | 
| Change in Patient Health Questionnaire - 8 (PHQ-8) | self reported depression symptoms | baseline versus week 4 | 
| Change in Beck Anxiety Inventory (BAI) Score | The Beck is a 21 item self-reported scale measuring anxiety | week 4 versus week 8 | 
| 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 |