Mechanisms of Stimulation for Pain Alleviation

Exclusion Criteria

• •Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
• •Active cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome
• •Painful polyneuropathy (e.g., metabolic, autoimmune, familial, infectious disease, environmental toxins, treatment with neurotoxic drug)
• •Chronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis)
• •Peripheral vascular disease
• •Diabetic neuropathy
• •Another pain diagnosis affecting the CNP site that could interfere with study procedures, accurate reporting and/or could confound evaluation of study endpoints (e.g., post-herpetic neuralgia)
• •Other active implantable devices (e.g., implantable cardioverter defibrillator, spinal cord stimulator, dorsal root ganglion stimulator, sacral nerve stimulator, deep brain stimulator, intrathecal pump)
• •Pregnancy, breastfeeding, or planning to conceive
• •Systemic infection or local infection at the anticipated PNS implant site
• •Immunocompromised state
• •Coagulation disorder, bleeding diathesis, platelet dysfunction, active anticoagulation
• •Interventional procedure and/or surgery to treat CNP in the last 30 days (subjects should be enrolled 30 days after last procedure, for prior ablative treatment must be enrolled at least 3 months after last procedure)
• •Untreated substance use disorder
• •Participating in another clinical trial with an active treatment arm
• •Numbness or loss of sensation at the bilateral thumbnails, peripheral neuropathy in the hands, circulatory or sensory problem in the hands\*
• •Participants with a history of Raynaud's Syndrome\*
• •Participants with SBP ≥150 and/or DBP ≥100\*
• •Prior radiation exposure of \>2 rem total within the last 12 months
• •Standard contraindications that would preclude MRI including pacemakers or other electronic implants, metal foreign objects or fragments in the eye or body, and aneurysm clips.
• •Claustrophobia
• •Inability to understand and communicate with the investigators to complete the study related questionnaires
• •Females with positive pregnancy test.