Clinical trial NCT03093935: StimRouter™ for Pain Management in Post-stroke Shoulder Pain
Official title: StimRouter™ Neuromodulation System: Implanted Peripheral Nerve Stimulation for Pain Management When Treating Patients With Chronic Post-stroke Shoulder-pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Hemiplegic Shoulder Pain
Keywords: Post-Stroke
Neuromodulation
Axillary nerve
Peripheral Nerve Stimulation
Lead sponsor: Bioness Inc
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort- Prospective, multi-center to collect population specific outcome measures in post-stroke patients
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Brief Pain Inventory (BPI) Change
timeFrame: Change from Baseline at Month 3
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC) Change
timeFrame: Change from Baseline at Month 3
measure: Patient Satisfaction
timeFrame: Month 3
measure: Standardized Shoulder Questionnaire (Shoulder Q) Change
timeFrame: Change from Baseline at Month 3
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Bioness Inc
name: Keith McBride
role: STUDY_CHAIR
References: