An interventional study of Hypersound RF-PNS system and Sham Hypersound in Chronic Neuropathic Pain, Radiculopathy and Sciatica, sponsored by Hypersound Medical Inc. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Hypersound Medical Inc · Not applicable, Interventional, and Treatment
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.
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.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 71 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →Hypersound Medical Inc is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Hypersound RF-PNS system
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.
Device: Sham Hypersound
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.
Also known as: Noninvasive peripheral nerve stimulator
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.
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.
Time frame: Baseline and 90 days after the first treatment
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.
Time frame: 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.
Time frame: 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.
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
Percentage of Participants Reporting Perceived Nerve Stimulation During Treatment
Participants are asked whether they perceived nerve stimulation during treatment sessions. The exact wording of the question and the method of aggregating responses across the ten sessions will be specified in the final protocol. Results support exploratory analyses of the relationship between perceived stimulation and pain response.
Time frame: During the five-week treatment course
Percentage of Participants Reporting Each Belief About Their Assigned Treatment
Participants are asked which treatment they believe they received, with response options of active, sham, or uncertain. This measure assesses the success of participant blinding and is collected before treatment assignment is disclosed.
Time frame: At the 90-day assessment, before disclosure of treatment assignment
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2027; primary completion for Mar 2028, 9 months later.
Of 215 interventional studies with no phase under Radiculopathy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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