StimRouter™ for Pain Management in Post-stroke Shoulder Pain

NCT03093935 | Terminated FDA Device

• 1 other identifier: STMR Pain 002 PSSP
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain; Hemiplegic Shoulder Pain

Keywords

Post-Stroke; Neuromodulation; Axillary nerve; Peripheral Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) Change

  The Brief Pain Inventory (BPI) form is a standard pain assessment tool based on a 0 to 10 scale. The Average Pain at Rest (BPI question number 5) score will be assessed at Baseline and approximately 3 months after programming (therapy start) to determine if there is a significant reduction in average pain with the addition of StimRouter TM treatment to standard of care.

  Change from Baseline at Month 3

Secondary Outcomes (3)

• Patient Global Impression of Change (PGIC) Change

  Change from Baseline at Month 3

• Patient Satisfaction

  Month 3

• Standardized Shoulder Questionnaire (Shoulder Q) Change

  Change from Baseline at Month 3

Study Arms (1)

StimRouter Neuromodulation System

EXPERIMENTAL

All eligible patients who are enrolled in this study will be treated with StimRouter stimulation therapy as part of standard of care for the entire duration of the study (6 months) and observed for post-market population-specific data. Standard recommended stimulation parameters for post-stroke shoulder pain include settings to elicit sensory response (paresthesia) as well as motor response (muscle contraction).

Device: StimRouter Neuromodulation System

Interventions

StimRouter Neuromodulation System DEVICE

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.

Also known as: StimRouter

StimRouter Neuromodulation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Bioness Inc: lead

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

University of Utah

Salt Lake City, Utah, 84123, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Keith McBride

  Bioness Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort- Prospective, multi-center to collect population specific outcome measures in post-stroke patients

Study Record Dates

• First Submitted: March 18, 2017
• First Posted: March 28, 2017
• Study Start: July 1, 2018
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: January 6, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)