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

NCT06626854 | Not Yet Recruiting Early Phase 1 FDA Device

• 1 other identifier: HMI01
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Knee Pain; Chronic Knee Osteoarthritis; Post Surgical Neuropathic Pain

Keywords

rfPNS; Hypersound; Neuroharmonix; Noninvasive PNS

Outcome Measures

Primary Outcomes (1)

• VAS

  Visual Analog Score Improvement of 50%

  3 months

Secondary Outcomes (1)

• Disability

  3 months

Study Arms (1)

Treatment

EXPERIMENTAL

Recipient of Hypersound Therapy

Device: RF-PNS

Interventions

RF-PNS DEVICE

Noninvasive peripheral nerve stimulator using interferential multi source radio frequency

Also known as: Noninvasive PNS, Hypersound

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain greater than mid-range using standardized pain inventory (SPI).
• No medication for pain both over-the-counter and by prescription for 24 hours prior to treatment.
• Body mass index (BMI) to be calculated for all participants with limitation for any BMI that is lower than normal. (Target is normal, overweight or obese).
• Age greater than 18.

You may not qualify if:

• Existing Peripheral Nerve Stimulator Implant in the lower extremities

Sponsors & Collaborators

• Hypersound Medical Inc: lead

Central Study Contacts

Tim Dickman, MS

CONTACT

(480) 278-9200; timd@hypersoundmedical.com

Gobi Paramanandnam, MD, MHSM

CONTACT

(480) 889-0180; gkparam@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share