NCT03093935

StimRouter™ for Pain Management in Post-stroke Shoulder Pain

StimRouter™ Neuromodulation System: Implanted Peripheral Nerve Stimulation for Pain Management When Treating Patients With Chronic Post-stroke Shoulder-pain

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Bioness Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Adults age 18 or over with severe intractable chronic shoulder pain subsequent to stroke will be included. Pain relief will be measured after using StimRouter stimulation therapy targeting the axillary nerve. Existing/pre-study pain medications must be either maintained, reduced throughout the trial. Study Design is prospective, multi-center and will include 50 subjects The primary endpoint will be a clinically relevant pain reduction (30%) in pain score at 3 months after initiating stimulation in at least 50% of patients with no increase in pain medication. Primary Outcomes: Reduction of average pain at rest measured by numeric scale (BPI-SF5) Secondary Outcomes 1. Change in Worst Pain (BPI-SF3) 2. Least Pain \& Pain Right Now (BPI - SF 4,6) 3. Patient Global Impression of Change (PGIC) 4. Patient Satisfaction questionnaire 5. Shoulder Q Data Collection Points 1\) Baseline 2) Month 1 post-programming 3) Month 2 post-programming 4) Month 3 post-programming 5) Month 6 post-programming Data Analysis Analyses will be made to evaluate differences in outcomes compared to baseline measures, with primary endpoint at Month 3 * Standard statistical estimation and inference will be undertaken for the observed treatment effect. * All adverse events will be tabulated by their frequencies and proportions.

Conditions

• Chronic Pain
• Hemiplegic Shoulder Pain

Interventions

Type	Name	Description
DEVICE	StimRouter Neuromodulation System	The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-11-20
• Completion: 2020-11-20
• First posted: 2017-03-28
• Last updated: 2021-01-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study