Empower Neuromodulation System - Pilot Study for Anxiety Treatment

Pilot Evaluation of the Empower Neuromodulation System for Anxiety Treatment

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.

Study Overview

• Status: Terminated
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Device: Empower Neuromodulation System

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5575
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active treatment; 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.	Device: Empower Neuromodulation System; Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Sham Comparator: Sham treatment; 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.	Device: Empower Neuromodulation System; Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Adherence	Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant	6 weeks
Usability	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".	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Nerve Stimulation	The percentage of treatment sessions that provide effective nerve stimulation as assessed via participant-reported confirmation of tingling sensation	6 weeks
Satisfaction With Treatment	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.	6 weeks
Number of Participants With Device-related Adverse Events	Safety assessment via device-related adverse events	6 weeks
Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to 6weeks	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.	6 weeks
Change in Participant-reported Beck Anxiety Inventory (BAI) Score From Baseline to 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.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Blinding to Treatment Group at 6 Weeks	Participant blinding to treatment group will be assessed. All participants will be asked if they believe that they have received the real treatment, with possible responses of Yes, No, or Don't Know. Then, for the active and sham treatment groups, the blinding index will be calculated, where the blinding index can range from -1 to 1. A score of 1 means that all participants have guessed correctly about group assignment, a score of -1 means that all participants have guessed incorrectly about group assignment.	6 weeks

Collaborators and Investigators

• Sponsor: Theranova, L.L.C.
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); University of Nebraska
• Investigators: Principal Investigator: Daniel Burnett, MD, TheraNova, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: CRD-12-1396-01; R43AT011497 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No