Clinical trial NCT04901481: Empower Neuromodulation System - Pilot Study for Anxiety Treatment
Official title: Pilot Evaluation of the Empower Neuromodulation System for Anxiety Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: University of Nebraska
First posted: 2021-05-25
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 6-week study.
Primary purpose: TREATMENT

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 randomized (1:1) to the active or sham treatment.

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 treat. First-line treatments for GAD include medication (e.g. SSRIs, SNRIs), cognitive behavioral therapy, or both in combination. Peripheral nerve stimulation via acupuncture has been shown to directly decrease clinical anxiety scores. The investigators have developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of anxiety. In this study, a randomized, controlled study will be conducted in participants with GAD. Participants will self-administer twice daily treatments with the Empower device. In this pilot study, the primary endpoints will be feasibility and acceptability, with safety and effectiveness evaluated as exploratory endpoints.

Eligibility criteria: Inclusion Criteria:

* ≥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 Criteria:

* 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

Primary outcomes:
measure: Treatment Adherence
timeFrame: 6 weeks
measure: Usability
timeFrame: 6 weeks
Secondary outcomes:
measure: Effective Nerve Stimulation
timeFrame: 6 weeks
measure: Satisfaction With Treatment
timeFrame: 6 weeks
measure: Number of Participants With Device-related Adverse Events
timeFrame: 6 weeks
measure: Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to 6weeks
timeFrame: 6 weeks
measure: Change in Participant-reported Beck Anxiety Inventory (BAI) Score From Baseline to 6 Weeks
timeFrame: 6 weeks
Other outcomes:
measure: Participant Blinding to Treatment Group at 6 Weeks
timeFrame: 6 weeks
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: TheraNova, LLC
name: Daniel Burnett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bang, Heejung et al. "Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol." Clinical Research and Regulatory Affairs 27 (2010): 42 - 51.