[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656887":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":44,"studyPopulation":38,"armGroups":45,"interventions":58,"overallOfficials":38,"centralContacts":69,"locations":75,"responsibleParty":89,"collaborators":38,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":38,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":38,"enrollmentInfo":100,"targetDuration":38,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":112,"overallStatus":117,"whyStopped":38,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Hypersound Medical Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline and 90 days after the first treatment",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":23},"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.","First treatment through 90 days after the first treatment; for participants who cross over, first active treatment through 90 days after that treatment",[25,29],{"measure":26,"description":27,"timeFrame":28},"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.","During the five-week treatment course",{"measure":30,"description":31,"timeFrame":32},"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.","At the 90-day assessment, before disclosure of treatment assignment",{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":38,"timePerspective":38,"maskingInfo":39},"RANDOMIZED","PARALLEL","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.","TREATMENT",null,{"masking":40,"maskingDescription":41,"whoMasked":42},"SINGLE","Participants are blinded to treatment assignment. The device operator may know assignment. Blinded outcome assessment and statistical analysis will be used where feasible.",[43],"PARTICIPANT","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.\n\nThe 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.\n\nAfter 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.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"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.",[51],"Device: Hypersound RF-PNS system",{"label":53,"type":54,"description":55,"interventionNames":56},"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.",[57],"Device: Sham Hypersound",[59,66],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"DEVICE","Hypersound RF-PNS system","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.",[47],[65],"Noninvasive peripheral nerve stimulator",{"type":60,"name":53,"description":67,"armGroupLabels":68,"otherNames":38},"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.",[53],[70],{"name":71,"role":72,"phone":73,"phoneExt":38,"email":74},"Tim Dickman","CONTACT","480-278-9200","timd@hypersoundmedical.com",[76],{"facility":77,"status":38,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":38},"Center for Pain and Supportive Care","Phoenix","Arizona","85028","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-112.07404,33.44838,{"lat":87,"lon":86},{"type":90,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100656887","hypersound-treatment-for-chronic-neuropathic-and-radicular-pain-100656887",false,"NCT07831447","Hypersound Treatment for Chronic Neuropathic and Radicular Pain","A Randomized, Participant-Blinded, Sham-Controlled Study of Noninvasive Hypersound Radiofrequency Neuromodulation for Chronic Neuropathic and Radicular Pain","Inclusion Criteria:\n\n* Age 18 years or older.\n* Clinically confirmed chronic neuropathic or radicular pain of at least three months' duration.\n* An identifiable anatomical treatment target.\n* Baseline pain meeting the minimum intensity threshold specified in the protocol.\n* Stable pain-treatment regimen as defined in the protocol.\n* Able to provide informed consent and to complete patient-reported assessments.\n* Willing to complete the treatment course and follow-up visits.\n\nExclusion Criteria:\n\n* Unstable medical or neurological disease.\n* Another dominant source of pain that would interfere with evaluation of the target pain condition.\n* Inability to reliably report outcomes.\n* Contraindications to the investigational device as specified in the protocol.\n* Major recent changes in pain treatment, as defined in the protocol.\n* Participation in another intervention likely to materially affect study outcomes.","ALL","18 Years",{"count":101,"type":102},71,"ESTIMATED","INTERVENTIONAL",[105],"NA","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.",[108,109,110,111],"Chronic Neuropathic Pain","Radiculopathy","Sciatica","Peripheral Neuropathic Pain",[113,114,115,116],"Hypersound","RF-PNS","Noninvasive peripheral nerve stimulation","Radiofrequency neuromodulation","NOT_YET_RECRUITING","2026-09-15",{"date":120,"type":121},"2026-09-21","ACTUAL",{"date":123,"type":102},"2027-06",{"date":125,"type":102},"2028-06",{"name":5,"class":6},1]