Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic… (NCT05287373) | Clinical Trial Compass
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Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain
United States89 participantsStarted 2022-02-23
Plain-language summary
This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is between 18 to 80 years of age at the time of enrollment.
✓. Subject would have been prescribed PNS therapy regardless of participation in this study; the use of the Nalu device must be on-label.
✓. Subject has been diagnosed with one or more of the conditions listed below in the low back, shoulder, knee, or foot (including ankle):Post-surgical/post-traumatic peripheral neuralgia including but not limited to pain due to peripheral nerve injury, post-surgical scar formation, nerve entrapment; Mononeuropathy, specified or unspecified or in diseases classified elsewhere; Other neuralgia or neuropathic pain; Osteoarthritic pain.
✓. Subject has chronic (defined as at least 6 months duration), intractable peripheral neuropathic pain, exclusive of the craniofacial region; any nociceptive pain must be less prominent than the neuropathic pain. Pain should have a predominant neuropathic component as per the investigator's clinical assessment.
✓. Subject should have a pain score of at least 6, in the target area of pain, as recorded on the BPI-Q5 (NRS) at screening.
✓. Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.
✓. Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.
✓. Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.
Exclusion criteria
✕. Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
What they're measuring
1
Effectiveness: Responder rates between groups
Timeframe: 3-months
2
Safety: Rate of serious and non-serious adverse events between groups
✕. Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant)
✕. Pain is completely absent at rest.
✕. Patient has clinical evidence of complex regional pain syndrome (CRPS), peripheral neuralgia of metabolic origin, post-herpetic neuralgia, biochemical evidence of a metabolic or genetic neuropathy (e.g., Charcot'- Marie- Tooth Disease) or mixed motor/sensory polyneuropathy.
✕. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
✕. Subject has had a successful (≥ 50% pain relief) interventional procedure within the past 3 months to treat the same pain condition(s) being examined in this study including, nerve blocks.
✕. Uncontrolled depression or uncontrolled psychiatric disorders
✕. Subject is currently participating in another clinical investigation with an active treatment arm.