StimRouter™ for Pain Management in Post-stroke Shoulder Pain

Stopped early · Not applicable

Conditions studied: Chronic Pain, Hemiplegic Shoulder Pain

In brief

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.

Key facts

Study ID

NCT03093935

Run by

Bioness Inc

People needed

6

Starts

2018-07-01

Expected to finish

2020-11-20

Last updated by the study team

2021-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami — Miami, Florida, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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