What this study is
This study will evaluate whether the investigational Hypersound system reduces pain in adults with chronic neuropathic or radicular pain. Hypersound uses externally positioned antennas to deliver radiofrequency energy intended to stimulate peripheral nerves without an implant. Approximately 71 participants will be randomly assigned in a two-to-one ratio to active Hypersound or sham treatment. Treatment consists of ten 15-minute sessions, twice weekly over five weeks. Participants will be unaware of their assigned treatment. The main comparison is the percentage of participants with at least a 50% decrease in average pain intensity at 90 days after the first treatment. Pain will be measured using a 100-mm visual analog scale referring to average pain over the preceding 24 hours. Safety and additional measures of pain and daily functioning will also be assessed. Participants initially assigned to sham will be offered active treatment after the 90-day assessment and followed for another 90 days after their first active treatment.
What's being tested
- Hypersound RF-PNS system
Intervention · DEVICE
A nonimplantable system that uses multiple externally positioned antennas to deliver controlled radiofrequency energy intended to stimulate peripheral nerves. Participants receive ten 15-minute sessions, twice weekly over five weeks, with antennas positioned for the participant's identified anatomical treatment target. Treatment uses the final verified system and the prospectively defined fluctuating-stimulation algorithm within established operating limits. Numerical treatment settings and the final algorithm are to be specified in the protocol.
- Sham Hypersound
Intervention · DEVICE
Sham use of the Hypersound system. Sessions match active treatment in positioning, antenna placement, session length, visit schedule, and interaction with study personnel, but do not deliver the intended therapeutic Hypersound exposure. Participants receive ten 15-minute sham sessions, twice weekly over five weeks. The exact sham operating method is to be finalized in the protocol. After the 90-day primary assessment, participants are offered the active treatment course.
Study details
- Official title
- A Randomized, Participant-Blinded, Sham-Controlled Study of Noninvasive Hypersound Radiofrequency Neuromodulation for Chronic Neuropathic and Radicular Pain
- Sponsor
- Hypersound Medical Inc
- Conditions
- Chronic Neuropathic Pain · Radiculopathy · Sciatica · Peripheral Neuropathic Pain
- Enrolling
- 71 people
- Starts
- 2027-06
- Est. completion
- 2028-06
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 18 years or older.
- Clinically confirmed chronic neuropathic or radicular pain of at least three months' duration.
- An identifiable anatomical treatment target.
- Baseline pain meeting the minimum intensity threshold specified in the protocol.
- Stable pain-treatment regimen as defined in the protocol.
- Able to provide informed consent and to complete patient-reported assessments.
- Willing to complete the treatment course and follow-up visits.
You can't join if
- Unstable medical or neurological disease.
- Another dominant source of pain that would interfere with evaluation of the target pain condition.
- Inability to reliably report outcomes.
- Contraindications to the investigational device as specified in the protocol.
- Major recent changes in pain treatment, as defined in the protocol.
- Participation in another intervention likely to materially affect study outcomes.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCenter for Pain and Supportive Care
Phoenix, Arizona, United States
Study team
Sponsor
Hypersound Medical Inc
Study ID HMI02
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.