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New treatment option for Peripheral Nerve Disorder
Official title Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device
ClinicalTrials.gov ID: NCT06772142
What this study is testing
- What it's testing
- A multicenter, 30 patient prospective single arm evaluation of the Nervonik system in symptomatic patients with chronic severe knee, elbow or shoulder pain. COHORT 1: The initial cohort of patients will receive the Nervonik neurostimulator for up to 8 hours.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Subject is between 18 to 80 years of age at the time of enrollment.
- Subject has been diagnosed with knee, arm, or shoulder chronic pain (NRS of at least 5 out of 10).
- Post-surgical/post-traumatic peripheral neuralgia including but not limited to pain due to peripheral nerve injury, post-surgical scar formation...
- 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.
You likely can't join if
- Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve...
- Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.
- Pain is completely absent at rest.
- Patient has clinical evidence of complex regional pain syndrome (CRPS), peripheral neuralgia of metabolic origin, post-herpetic neuralgia...
- 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) treatment procedure within the past 3 months to treat the same pain condition(s) being examined in...
See the full eligibility criteria
Who can join
- Subject is between 18 to 80 years of age at the time of enrollment.
- Subject has been diagnosed with knee, arm, or shoulder chronic pain (NRS of at least 5 out of 10).
- 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...
- 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.
- Subject is psychologically qualified to receive a peripheral nerve stimulator as per the clinician's standard clinical practice and judgment and does not have clinically relevant psychological condition(s) that would...
- Subject has demonstrated the ability to appropriately place the wearable in the location where the IPG is most likely to be implanted. Alternatively, subject is able to appropriately use the relief belt and/or limb cuff...
What rules you out
- 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.
- Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.
- 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'-...
- 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) treatment 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.
- Subject is allergic or sensitive to materials used in the device components including, skin adhesives or does not tolerate the wearable aspect of the device.
- Subject has pending or ongoing legal issues (including unresolved worker's compensation claims or equivalent) or other conflicting secondary gain issues related to their chronic pain condition.
- Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease that has not been medically corrected.
- Subject has an active systemic infection.
- Subject is unable to read and/or write in Spanish or give informed consent.
- Subject has a life expectancy of less than 1 year
- Subject has an active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome.
- Subject with uncontrolled diabetes mellitus, showing signs of diabetic neuropathy, as evidenced by a neurological exam and a HbA1c test.
- Subject has evidence of an alcohol or drug dependency within the last 6 months prior to enrollment.
- Subject is pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 1 year post-menopausal).
- Subject is nursing/breastfeeding.
- Subject is on ≥90 mg-morphine equivalents per 24 hours. Recommend 60.
- Subject has undergone an ablative treatment of the target peripheral nerve, or proximal nerve trunk giving rise to the target nerve, or dorsal roots (and DRGs) that ultimately make up the target nerve. No ablative...
The study team makes the final eligibility decision.
Where it's taking place
- Panama City, Provincia de Panamá, Panama
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Panama City, Provincia de Panamá, Panama. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.