StimRouter™ for Pain Management in Post-stroke Shoulder Pain
TerminatedNot applicableNCT03093935
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
StimRouter Neuromodulation System includes an implanted lead which provides peripheral nerve stimulation for chronic pain. Post-stroke shoulder pain patients will be the focus of this study. After meeting inclusion/exclusion criteria, approximately 50 enrolled patients will participate in the study through 6 months of follow-up. Various measures will be used to assess patient response to use of the device.
Study details
- Official title
- StimRouter™ Neuromodulation System: Implanted Peripheral Nerve Stimulation for Pain Management When Treating Patients With Chronic Post-stroke Shoulder-pain
- Conditions
- Chronic Pain
- Hemiplegic Shoulder Pain
- Interventions
- Device: StimRouter Neuromodulation System
- Sponsor
- Bioness Inc
- Start date
- 2018-07-01
- Primary completion
- 2020-11-20
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03093935