Empower Neuromodulation System - Pilot Study for Anxiety Treatment

NCT04901481 | Terminated Results DMC FDA Device

• 2 other identifiers: CRD-12-1396-01R43AT011497
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Effective Nerve Stimulation

  6 weeks

• Satisfaction With Treatment

  6 weeks

• Number of Participants With Device-related Adverse Events

  6 weeks

• Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to 6weeks

  6 weeks

• Change in Participant-reported Beck Anxiety Inventory (BAI) Score From Baseline to 6 Weeks

  6 weeks

Other Outcomes (1)

• Participant Blinding to Treatment Group at 6 Weeks

  6 weeks

Study Arms (2)

Active treatment

EXPERIMENTAL

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

Sham treatment

SHAM COMPARATOR

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

Interventions

Empower Neuromodulation System DEVICE

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

Active treatment; Sham treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theranova, L.L.C.: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Nebraska: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5575, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical
• Organization: TheraNova, LLC

clinicalstudy@theranova.com

4159268616

Study Officials

• Daniel Burnett, MD

  TheraNova, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research staff will not provide any details that would cause participants to become unblinded to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 6-week study.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: September 17, 2021
• Primary Completion: July 28, 2022
• Study Completion: May 17, 2023
• Last Updated: June 20, 2024
• Results First Posted: June 20, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)