Hypersound Treatment for Chronic Neuropathic and Radicular Pain

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hypersound Medical Inc
Study ID
NCT07831447
Status
Not Yet Recruiting

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Conditions

  • Chronic Neuropathic Pain
  • Peripheral Neuropathic Pain
  • Radiculopathy
  • Sciatica

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypersound RF-PNS system — DEVICE
    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 — DEVICE
    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 Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Jun 30, 2027
Status verified
Sep 2026
Primary completion
Mar 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
71 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Hypersound
    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.
  • Sham Comparator: Sham Hypersound
    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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Pain and Supportive CarePhoenixArizona85028-

Find similar trials in Phoenix, AZ

By research site
Center for Pain and Supportive Care· Phoenix, AZ

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