Phase
Condition
Neurologic Disorders
Treatment
Peripheral Nerve Stimulation
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 paindue to peripheral nerve injury, post-surgical scar formation, nerve entrapment;Mononeuropathy, specified or unspecified or in diseases classified elsewhere; Otherneuralgia or neuropathic pain
Subject is willing to cooperate with the study requirements including, compliancewith the study procedures and completion of all study visits.
Subject reported stable pain (non-escalating) for 60 days prior to signing informedconsent.
Subject is currently receiving CMM and has had stable pain medication use and dosagefor 30 days prior to signing informed consent.
Subject is psychologically qualified to receive a peripheral nerve stimulator as perthe clinician's standard clinical practice and judgment and does not have clinicallyrelevant psychological condition(s) that would interfere with their ability toaccurately report outcomes or complete study procedures.
Subject has demonstrated the ability to appropriately place the wearable in thelocation where the IPG is most likely to be implanted. Alternatively, subject isable to appropriately use the relief belt and/or limb cuff to keep the wearable inplace.
Exclusion
Exclusion Criteria:
Subject currently has an active implantable medical device such as a drug pump,spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deepbrain stimulator, and/or cardiac pacemaker.
Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal RootGanglion (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), peripheralneuralgia of metabolic origin, post-herpetic neuralgia, biochemical evidence of ametabolic or genetic neuropathy (e.g., Charcot'- Marie- Tooth Disease) or mixedmotor/sensory polyneuropathy.
Subject has a medical condition that would prevent them from participating in thecurrent study per investigator's or medical monitor's judgment.
Subject has had a successful (≥ 50% pain relief) interventional procedure within thepast 3 months to treat the same pain condition(s) being examined in this studyincluding, nerve blocks.
Uncontrolled depression or uncontrolled psychiatric disorders
Subject is currently participating in another clinical investigation with an activetreatment arm.
Subject is allergic or sensitive to materials used in the device componentsincluding, skin adhesives or does not tolerate the wearable aspect of the device.
Subject has pending or ongoing legal issues (including unresolved worker'scompensation claims or equivalent) or other conflicting secondary gain issuesrelated to their chronic pain condition.
Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, orprogressive 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 ofparaneoplastic 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 priorto enrollment.
Subject is pregnant (if female and sexually active, subject must be using a reliableform 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, orproximal nerve trunk giving rise to the target nerve, or dorsal roots (and DRGs)that ultimately make up the target nerve. No ablative procedures directed at thespinal cord, dorsal roots, or peripheral nerve(s) being treated in the study. Tonote, subjects who have undergone RF ablation of the dorsal rami, cool pulsed RF ofthe facet innervation may be considered for enrollment
Study Design
Connect with a study center
Hospital Punta Pacifica
Panama City, 0831-01593
PanamaActive - Recruiting
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