Hypersound Treatment for Chronic Neuropathic and Radicular Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHypersound Medical Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Hypersound RF-PNS system
DeviceA 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
DeviceSham 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.
Treatment groups
71 Participants
are divided into 2 treatment groupsGroup A: Active HypersoundExperimental treatment 1 intervention
Group B: Sham HypersoundSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
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 treatment2
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 treatment3
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 treatmentOther outcomes
1
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 course2
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 assignmentSponsors and contacts
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Source ClinicalTrials.gov
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