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

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

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06626854
Enrollment
5
Registered
2024-10-04
Start date
2026-06-10
Completion date
2026-12-10
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Knee Osteoarthritis, Chronic Knee Pain, Post Surgical Neuropathic Pain

Keywords

rfPNS, Hypersound, Neuroharmonix, Noninvasive PNS

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.

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

Interventions

DEVICERF-PNS

Noninvasive peripheral nerve stimulator using interferential multi source radio frequency

Sponsors

Hypersound Medical Inc
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
VAS3 monthsVisual Analog Score Improvement of 50%

Secondary

MeasureTime frameDescription
Disability3 monthsOswestry disability index improvement of greater than 50%

Contacts

CONTACTTim Dickman, MS
timd@hypersoundmedical.com(480) 278-9200
CONTACTGobi Paramanandnam, MD, MHSM
gkparam@gmail.com(480) 889-0180

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026