NCT04901481

Empower Neuromodulation System - Pilot Study for Anxiety Treatment

Pilot Evaluation of the Empower Neuromodulation System for Anxiety Treatment

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Theranova, L.L.C. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Generalized anxiety disorder (GAD) is a chronic, recurring condition that affects approximately 6.4 million American adults each year. GAD is one of the most common anxiety disorders and is costly to treat. First-line treatments for GAD include medication (e.g. SSRIs, SNRIs), cognitive behavioral therapy, or both in combination. Peripheral nerve stimulation via acupuncture has been shown to directly decrease clinical anxiety scores. The investigators have developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of anxiety. In this study, a randomized, controlled study will be conducted in participants with GAD. Participants will self-administer twice daily treatments with the Empower device. In this pilot study, the primary endpoints will be feasibility and acceptability, with safety and effectiveness evaluated as exploratory endpoints.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-17
• Primary completion: 2022-07-28
• Completion: 2023-05-17
• First posted: 2021-05-25
• Last updated: 2024-06-20
• Results posted: 2024-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study