Status:
TERMINATED
Empower Neuromodulation System - Pilot Study for Anxiety Treatment
Lead Sponsor:
Theranova, L.L.C.
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
University of Nebraska
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This study evaluates the effects of peripheral nerve stimulation on anxiety levels in participants with Generalized Anxiety Disorder (GAD). This is a pilot investigation in which participants will ran...
Detailed Description
Generalized anxiety disorder (GAD) is a chronic, recurring condition that affects approximately 6.4 million American adults each year. GAD is one of the most common anxiety disorders and is costly to ...
Eligibility Criteria
Inclusion
- ≥19 years old
- Current diagnosis of GAD per DSM-5 via M.I.N.I. assessment by clinician
- Hamilton Anxiety Rating Scale (HAM-A) ≥18
- Negative urine pregnancy test at screening (females only)
- Able to provide informed consent
- Capable and willing to follow all study-related procedures
Exclusion
- Has current (past 30 days) psychotic or bipolar disorder, homicidal ideation, psychiatric hospitalization, or moderate/severe substance use disorders per clinician assessment via M.I.N.I.
- Hamilton Depression Rating Scale (HAM-D) ≥18
- PTSD Checklist for DSM-5 (PCL-5) ≥51
- Exhibits suicidal intent as confirmed on the Columbia-Suicide Severity Rating Scale-Revised (C-SSRS-R) with a "Yes" response to question 4 or question 5 or to question 6 in the past 3 months.
- Changes in psychoactive medications in the past 30 days (including but not limited to psychotropic medications, thyroid hormone medication, steroids), with the exception of benzodiazepines
- If regularly taking benzodiazepines, has had changes in benzodiazepine dosing in the past 30 days or average use \>2 days per week
- Psychotherapy was initiated or discontinued in the past 30 days or psychotherapy modality was changes in the past 30 days
- Has a history of epilepsy or a seizure disorder
- Has been diagnosed with peripheral nerve damage of the arm or hand or has numbness or tingling in the arm or hand at least weekly
- Is currently pregnant or breastfeeding, has been pregnant within the past 6 months or intends to become pregnant during the study period
- Currently has an active implant and/or an electrical or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant
- Has an electrically conductive metal object (e.g. jewelry) that cannot be removed from the upper extremities and will directly contact the gel electrodes of the Empower Neuromodulation System at the active or sham anatomic location
- Has an open incision, wound, scar, active infection or otherwise compromised skin that will directly contact the gel electrodes of the Empower Neuromodulation System at either the active or sham anatomic location
- Does not have daily access to an electrical outlet for charging the investigational device and associated smartphone
- Has used of an investigational drug/device therapy within the past four weeks
- Unable to provide informed written consent
- Has any medical condition that would, in the opinion of the investigator, make the participant ineligible
Key Trial Info
Start Date :
September 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04901481
Start Date
September 17 2021
End Date
May 17 2023
Last Update
June 20 2024
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5575