Empower Neuromodulation System - Pilot Study for Anxiety Treatment

NCT ID: NCT04901481

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2023-05-17

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Empower Neuromodulation System

Intervention Type: DEVICE

Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

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.

Group Type: SHAM_COMPARATOR

Empower Neuromodulation System

Intervention Type: DEVICE

Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: collaborator

Theranova, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Burnett, MD

Role: PRINCIPAL_INVESTIGATOR

TheraNova, LLC

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R43AT011497

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CRD-12-1396-01

Identifier Type: -

Identifier Source: org_study_id