Empower Neuromodulation System - Pilot Study for Anxiety Treatment

Not Applicable

Terminated

Conditions: Generalized Anxiety Disorder

Interventions: Device: Empower Neuromodulation System

Registration Number: NCT04901481

Lead Sponsor: Theranova, L.L.C.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 18

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active treatment	Empower Neuromodulation System	Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment.
Sham treatment	Empower Neuromodulation System	Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment.

Primary Outcome Measures

Name	Time	Method
Usability	6 weeks	Acceptability as assessed via a usability assessment (System Usability Scale (SUS)). For the SUS, the score range is 0 to 100, with a higher score indicating the stimulation system's better usability. The survey includes 10 questions in which statements about the system are rated from "Strongly disagree" up to "Strongly agree".
Treatment Adherence	6 weeks	Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Treatment	6 weeks	The overall satisfaction with treatment (via 100-mm Visual-Analog Scale (VAS)). For the VAS, the score range is 0 to 100, with a higher scoring meaning higher satisfaction.
Number of Participants With Device-related Adverse Events	6 weeks	Safety assessment via device-related adverse events
Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to 6weeks	6 weeks	Anxiety severity evaluation via clinician-administered Hamilton Anxiety Rating Scale (HAM-A) score. For the HAM-A, the score range is 0 to 56, with a higher scoring meaning more severe anxiety.
Effective Nerve Stimulation	6 weeks	The percentage of treatment sessions that provide effective nerve stimulation as assessed via participant-reported confirmation of tingling sensation
Change in Participant-reported Beck Anxiety Inventory (BAI) Score From Baseline to 6 Weeks	6 weeks	Anxiety severity evaluation via participant-reported Beck Anxiety Inventory (BAI) score from Baseline to 6 weeks. For the BAI, the score range is 0 to 63, with a higher scoring meaning more severe anxiety.