NCT05948605

EMPOWER AUD Pivotal Trial

Evaluation of the Empower Neuromodulation System for the Treatment of Alcohol Use Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Theranova, L.L.C. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

To evaluate the safety and effectiveness of the Empower Neuromodulation System in alcohol use disorder (AUD) patients. The primary safety endpoint will be device-related serious adverse events. The primary effectiveness endpoint will be responder rate at 12 weeks, where a responder is defined as a subject who experiences at least a one level reduction in the WHO risk level for daily alcohol consumption from Baseline to Week 12 as measured via the 28-day Timeline Follow-back (TLFB). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.

Conditions

• Alcoholism
• Alcohol Abuse
• Alcohol Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-08-06
• Completion: 2025-08-06
• First posted: 2023-07-17
• Last updated: 2025-08-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study