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NOT YET RECRUITING
NCT06626854
EARLY_PHASE1

Treating Chronic Pain of Peripheral Nerve Origin With the Novel Noninvasive Hypersound Neuromodulation System

Sponsor: Hypersound Medical Inc

View on ClinicalTrials.gov

Summary

First, the subject will undergo screening and provide informed consent. Baseline measurements are then taken. The subject remains seated with back support throughout the session. The technician verifies and marks the knee for treatment and wraps an antenna applicator strap around the lower leg near the knee. The device is turned on in test mode to confirm the therapy location, with the subject identifying when they feel a sensation over their pain area. The power threshold for this sensation is recorded. The therapy, which lasts 15 minutes, is delivered at 90% of this threshold to ensure the subject does not feel it. After therapy, post-treatment measurements are taken.

Official title: Prospective, Randomized Study to Assess the Safety and Efficacy of the Novel Noninvasive Hypersound Neuromodulation System in the Treatment of Patients With Chronic Pain of Peripheral Nerve Origin, Including Neuropathy, Sciatica, and Joint Pain

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2026-06-10

Completion Date

2026-12-10

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DEVICE

RF-PNS

Noninvasive peripheral nerve stimulator using interferential multi source radio frequency