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EMPOWER AUD Pivotal Trial

NCT05948605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-08-11

No results posted yet for this study

Summary

Multi-site, double-blinded, prospective, randomized, sham-controlled study

Conditions

Interventions

DEVICE

Empower Neuromodulation System

The Empower Neuromodulation System is designed to provide transcutaneous stimulation to the branches of a spinal nerve. The system comprised of three key components: (A) The Stimulator, (B) the Empower smartphone app, and (C) the Gel Patch. The smartphone application is used to coordinate treatment and record participant responses.

Sponsors & Collaborators

  • Theranova, L.L.C.

    lead INDUSTRY

Principal Investigators

  • KT Venkateswara-Rao, PhD · TheraNova, LLC

  • David Pennington, PhD · Northern California Institute of Research and Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-08-06
Completion
2025-08-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05948605 on ClinicalTrials.gov