NCT03983317

Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Theranova, L.L.C. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD). This is a pilot investigation in which all participants will receive the active treatment.

Detailed description

Alcohol use disorder (AUD) is a major public health concern, affecting over 16 million Americans. Peripheral nerve stimulation via acupuncture has been shown to directly decrease alcohol craving and self-administration. TheraNova has developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of AUD. In this study, we will conduct a cross-over, home-use study in participants with AUD. Participants will have a one-week control period with no treatment followed by two weeks of twice daily treatment with the Empower device. We will evaluate endpoints for safety and effectiveness.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DEVICE	Empower Neuromodulation System	Transcutaneous electrical nerve stimulation

Timeline

• Start date: 2019-05-20
• Primary completion: 2020-03-26
• Completion: 2020-03-26
• First posted: 2019-06-12
• Last updated: 2020-11-18
• Results posted: 2020-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study