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StimRouter™ for Pain Management in Post-stroke Shoulder Pain (PSSP)

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ClinicalTrials.gov Identifier: NCT03093935
Recruitment Status : Not yet recruiting
First Posted : March 28, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Bioness Inc

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Hemiplegic Shoulder Pain Device: StimRouter Neuromodulation System Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort- Prospective, multi-center to collect population specific outcome measures in post-stroke patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: StimRouter™ Neuromodulation System: Implanted Peripheral Nerve Stimulation for Pain Management When Treating Patients With Chronic Post-stroke Shoulder-pain
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: StimRouter Neuromodulation System

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
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.
Other Name: StimRouter



Primary Outcome Measures :
  1. Brief Pain Inventory (BPI) Change [ Time Frame: Change from Baseline at Month 3 ]
    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.


Secondary Outcome Measures :
  1. Patient Global Impression of Change (PGIC) Change [ Time Frame: Change from Baseline at Month 3 ]
    Patient Global Impression of Change (PGIC) survey assesses perceived overall change in a combination of pain and life quality

  2. Patient Satisfaction [ Time Frame: Month 3 ]
    Patient Satisfaction will be measured by a numeric (i.e., 1-5) rating scale (NRS)

  3. Standardized Shoulder Questionnaire (Shoulder Q) Change [ Time Frame: Change from Baseline at Month 3 ]
    Change in difficulty level (on a scale from 0 to 3) or ability (yes/no) for completing normal day-to-day activities such as combing hair or lifting an 8 pound container to the shoulder level without bending the elbow, as measured by the Shoulder Q standardized questionnaire.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093935


Contacts
Contact: Keith McBride (661) 362-4866 keith.mcbride@bioness.com
Contact: Charlene Myers 9499101655 charlene.myers@bioness.com

Locations
United States, Florida
Brooks Rehabilitation Hospital Recruiting
Jacksonville, Florida, United States, 32216
Contact: Raine Osborne    904-345-7373    Raine.Osborne@Brooksrehab.org   
Principal Investigator: Kenneth Ngo, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84123
Contact: Heidi Hansen    801-585-2373    Heidi.hansen@hsc.utah.edu   
Contact: Mary Pautler    801.585.2373    mary.pautler@hsc.utah.edu   
Principal Investigator: Heather Hayes, NCS, PhD         
Sponsors and Collaborators
Bioness Inc
Investigators
Study Chair: Keith McBride Bioness Inc

Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT03093935     History of Changes
Other Study ID Numbers: STMR Pain 002 PSSP
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Bioness Inc:
Post-Stroke
Neuromodulation
Axillary nerve
Peripheral Nerve Stimulation

Additional relevant MeSH terms:
Chronic Pain
Shoulder Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases