Hypersound Treatment for Chronic Neuropathic and Radicular Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Sham Hypersound: 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 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. 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

Primary outcome measure(s)

• Percentage of Participants Achieving at Least a 50% Reduction in Average Pain Intensity — 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.

Trial sites (1)

Other trials for the same condition