StimRouter™ for Pain Management in Post-stroke Shoulder Pain "PSSP"

Not yet recruiting

Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

- Male or female age ≥18 years and confirmed diagnosis of stroke
- Competent to provide consent and comply with study requirements
- Minimum 3 months of severe chronic focal post-stroke shoulder pain
- Stable regimen of pain medications for >4 weeks prior to implant and willing to maintain equivalent dosage throughout the study
- A mean score of > 4 on the Brief Pain Inventory short form, question 3 (BPI-SF3)
- Capable and willing to follow all study-related procedures
- Able to tolerate surface stimulation as demonstrated by motor level response at shoulder

Exclusion Criteria

- Patients who decline to provide written consent or to attend follow-up visits
- Shoulder pathology (e.g. rotator cuff tear, frozen shoulder etc) at target limb
- Evidence of a primary central or regional pain pattern inclusive of shoulder
- Diagnosed/confirmed shoulder dysfunction
- Botox or other neurolytic agent injections in last 3 months
- Any confounding neurologic conditions affecting the upper limb
- Evidence or history of skin infections
- History of adverse reactions to local anesthetics (e.g. lidocaine) or adhesives
- Patients who have an active systemic infection or are immunocompromised
- Patients who are pregnant, intend to become pregnant, are breastfeeding or of child-bearing potential and not practicing a medically-approved method of birth control
- Currently requiring or likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone defined as within 50cm of the iso-center or 16 cm of the MR coil as measured from the edge of the MRI coil.
- Any metallic implant in the immediate area intended for implant (e.g. TSR)
- Has demand-type cardiac pacemaker, defibrillator, or electrical nerve implant
- Potential need for diathermy at the implant site
- Potential need for therapeutic ultrasound at the implant site
- Patients who have already been implanted with StimRouter TM prior to study enrollment
- Presence of a documented condition or abnormality that could compromise the safety of the patient
- Life expectancy of less than 1 year