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

February 19, 2026 updated by: Hypersound Medical Inc

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Subject will perform screening and informed consent
  2. Baseline measurements will be taken
  3. Subject will sit in chair with back support throughout duration of the session
  4. Knee for treatment will be verified and marked
  5. Technician will wrap antenna applicator strap around the lower leg, at the knee
  6. Device is turned on and set to test mode to verify therapy location. Subject will verify when they feel a sensation covering their existing chronic knee pain. The power threshold for sensation is recorded.
  7. Therapy begins and lasts for 15 minutes, power threshold is set to 90% so that the subject does not feel the therapy
  8. At the end of 15 minutes, post-therapy measurements are recorded

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Gobi Paramanandnam, MD, MHSM
  • Phone Number: (480) 889-0180
  • Email: gkparam@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Existing Peripheral Nerve Stimulator Implant in the lower extremities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Recipient of Hypersound Therapy
Device: RF-PNS
Noninvasive peripheral nerve stimulator using interferential multi source radio frequency
Other Names:
  • Noninvasive PNS
  • Hypersound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 3 months
Visual Analog Score Improvement of 50%
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 3 months
Oswestry disability index improvement of greater than 50%
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hypersound Medical Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2026

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

December 10, 2026

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMI01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Staff and research team aren't supported to persist the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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