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Empower Neuromodulation System - Pilot Study for Anxiety Treatment

NCT04901481 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-06-20

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of Nebraska

    collaborator OTHER

  • Theranova, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Daniel Burnett, MD · TheraNova, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2022-07-28
Completion
2023-05-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04901481 on ClinicalTrials.gov