Anxiety Clinical Trial
Official title:
Fisher Wallace Brain Stimulation & Generalized Anxiety Study
Verified date | February 2021 |
Source | ProofPilot |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | ProofPilot (Remote Virtual Trial) | New York | New York |
Lead Sponsor | Collaborator |
---|---|
ProofPilot | Fisher Wallace |
United States,
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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