Chronic Neuropathic PainNCT07831447
Hypersound Treatment for Chronic Neuropathic and Radicular Pain
A study testing Hypersound RF-PNS system in people with Chronic Neuropathic Pain and Radiculopathy, run by Hypersound Medical Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Neuropathic Pain, Radiculopathy, Sciatica
- What is being tested?
- Hypersound RF-PNS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Center for Pain and Supportive Care
Phoenix, Arizona, 85028
About this study
Official title: A Randomized, Participant-Blinded, Sham-Controlled Study of Noninvasive Hypersound Radiofrequency Neuromodulation for Chronic Neuropathic and Radicular Pain
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.
Read the detailed description
This prospective, randomized, participant-blinded, sham-controlled investigation evaluates the safety and preliminary efficacy of noninvasive Hypersound radiofrequency peripheral nerve stimulation in adults with chronic neuropathic or radicular pain, including lumbosacral radicular pain and peripheral neuropathic pain affecting the upper or lower extremities. Enrollment will follow completion of the applicable UG3 engineering, safety, and clinical-readiness milestones.
The study targets approximately 60 evaluable participants from 71 enrolled participants. Active treatment uses multiple external antennas and a prospectively defined fluctuating-stimulation algorithm within verified operating limits. Sham treatment resembles active treatment in positioning, antenna placement, duration, visit schedule, and interactions with personnel, without delivering the intended therapeutic exposure. Participants are blinded; operators may know assignment, with blinded outcome assessment and statistical analysis where feasible.
After the randomized 90-day assessment, participants initially assigned to sham are offered active treatment. Post-crossover outcomes are analyzed separately. Supportive analyses will examine perceived nerve stimulation and its relationship to pain response. Prior feasibility observations of perceived stimulation do not establish analgesic efficacy.
- Being tested
- Hypersound RF-PNS system, Sham Hypersound
- Keywords
- Hypersound, RF-PNS, Noninvasive peripheral nerve stimulation, Radiofrequency neuromodulation
- Medical subject headings
- Radiculopathy, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypersound RF-PNS systemDevice
Also called Noninvasive peripheral nerve stimulator
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 HypersoundDevice
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 group | Role | What they receive |
|---|---|---|
| Active Hypersound | Experimental | Ten 15-minute sessions of active Hypersound radiofrequency peripheral nerve stimulation, twice weekly over five weeks. External antennas are positioned for the identified anatomical treatment target. Treatment uses the final verified system and prospectively defined fluctuating-stimulation algorithm within established operating limits. Receives: Device: Hypersound RF-PNS system |
| Sham Hypersound | Sham comparator | Participants undergo a procedure resembling active treatment, including comparable positioning, antenna placement, device and personnel interaction, and ten 15-minute sessions twice weekly over five weeks, without the intended therapeutic Hypersound exposure. After the 90-day primary assessment, participants are offered active treatment and are followed for 90 days after their first active treatment. Receives: Device: Sham Hypersound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving at Least a 50% Reduction in Average Pain Intensity
Pain intensity is assessed with a 100-mm visual analog scale (VAS) ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with lower scores indicating less pain. Participants rate their average pain during the preceding 24 hours. Baseline is assessed before the first treatment. A responder is a participant whose VAS score decreases by at least 50% from baseline at the 90-day assessment. The percentage of responders is compared between the randomized active Hypersound and sham groups.
Measured: Baseline and 90 days after the first treatment
Secondary outcomes (3)
Change From Baseline in Average 24-Hour Pain Intensity on the 100-mm VAS
Average pain intensity over the preceding 24 hours is rated on a 100-mm visual analog scale (VAS) ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with lower scores indicating less pain. Change is calculated as the day-90 score minus the baseline score, so negative values indicate improvement.
Measured: Baseline and 90 days after the first treatment
Percentage of Participants Achieving at Least a 30% Reduction in Average Pain Intensity
Average pain intensity over the preceding 24 hours is rated on a 100-mm visual analog scale (VAS) ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with lower scores indicating less pain. A responder is a participant whose VAS score decreases by at least 30% from baseline at the 90-day assessment.
Measured: Baseline and 90 days after the first treatment
Percentage of Participants Experiencing Adverse Events
Adverse events are collected and characterized by severity, seriousness, expectedness, and relationship to the device or to study treatment. Events occurring during the randomized period are summarized separately from events occurring after crossover to active treatment.
Measured: First treatment through 90 days after the first treatment; for participants who cross over, first active treatment through 90 days after that treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startJun 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized approximately 2:1 to active Hypersound or sham treatment. Sham participants are offered active treatment after the randomized 90-day primary assessment; post-crossover outcomes are analyzed separately.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hypersound Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831447
- Sponsor's protocol ID
- HMI02
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Participant-Blinded, Sham-Controlled Study of Noninvasive Hypersound Radiofrequency Neuromodulation for Chronic Neuropathic and Radicular Pain
- ClinicalTrials.gov ID
- NCT07831447
- Acronym / sponsor ID
- HMI02
- Keywords
- Hypersound, RF-PNS, Noninvasive peripheral nerve stimulation, Radiofrequency neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Hypersound Medical IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, randomized, participant-blinded, sham-controlled investigation evaluates the safety and preliminary efficacy of noninvasive Hypersound radiofrequency peripheral nerve stimulation in adults with chronic neuropathic or radicular pain, including lumbosacral radicular pain and peripheral neuropathic pain affecting the upper or lower extremities. Enrollment will follow completion of the applicable UG3 engineering, safety, and clinical-readiness milestones.
The study targets approximately 60 evaluable participants from 71 enrolled participants. Active treatment uses multiple external antennas and a prospectively defined fluctuating-stimulation algorithm within verified operating limits. Sham treatment resembles active treatment in positioning, antenna placement, duration, visit schedule, and interactions with personnel, without delivering the intended therapeutic exposure. Participants are blinded; operators may know assignment, with blinded outcome assessment and statistical analysis where feasible.
After the randomized 90-day assessment, participants initially assigned to sham are offered active treatment. Post-crossover outcomes are analyzed separately. Supportive analyses will examine perceived nerve stimulation and its relationship to pain response. Prior feasibility observations of perceived stimulation do not establish analgesic efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomized approximately 2:1 to active Hypersound or sham treatment. Sham participants are offered active treatment after the randomized 90-day primary assessment; post-crossover outcomes are analyzed separately.
| Arm | Type | Receives |
|---|---|---|
| Active Hypersound | Experimental | Device: Hypersound RF-PNS systemTen 15-minute sessions of active Hypersound radiofrequency peripheral nerve stimulation, twice weekly over five weeks. External antennas are positioned for the identified anatomical treatment target. Treatment uses the final verified system and prospectively defined fluctuating-stimulation algorithm within established operating limits. |
| Sham Hypersound | Sham comparator | Device: Sham HypersoundParticipants undergo a procedure resembling active treatment, including comparable positioning, antenna placement, device and personnel interaction, and ten 15-minute sessions twice weekly over five weeks, without the intended therapeutic Hypersound exposure. After the 90-day primary assessment, participants are offered active treatment and are followed for 90 days after their first active treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypersound RF-PNS systemAlso: Noninvasive peripheral nerve stimulatorA 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. | Device | Active Hypersound |
| Sham HypersoundSham 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. | Device | Sham Hypersound |
Primary outcome
Percentage of Participants Achieving at Least a 50% Reduction in Average Pain Intensity
Time frame: Baseline and 90 days after the first treatment
Pain intensity is assessed with a 100-mm visual analog scale (VAS) ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with lower scores indicating less pain. Participants rate their average pain during the preceding 24 hours. Baseline is assessed before the first treatment. A responder is a participant whose VAS score decreases by at least 50% from baseline at the 90-day assessment. The percentage of responders is compared between the randomized active Hypersound and sham groups.
3 secondary outcomes
Change From Baseline in Average 24-Hour Pain Intensity on the 100-mm VAS
Time frame: Baseline and 90 days after the first treatment
Percentage of Participants Achieving at Least a 30% Reduction in Average Pain Intensity
Time frame: Baseline and 90 days after the first treatment
Percentage of Participants Experiencing Adverse Events
Time frame: First treatment through 90 days after the first treatment; for participants who cross over, first active treatment through 90 days after that treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypersound RF-PNS system in people with Chronic Neuropathic Pain and Radiculopathy, run by Hypersound Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Dickman (480-278-9200, timd@hypersoundmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving at Least a 50% Reduction in Average Pain Intensity (time frame: Baseline and 90 days after the first treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.