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

Primary Purpose

Chronic Pain, Hemiplegic Shoulder Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
StimRouter Neuromodulation System
Sponsored by
Bioness Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Post-Stroke, Neuromodulation, Axillary nerve, Peripheral Nerve Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami
  • University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

StimRouter Neuromodulation System

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Global Impression of Change (PGIC) Change
Patient Global Impression of Change (PGIC) survey assesses perceived overall change in a combination of pain and life quality
Patient Satisfaction
Patient Satisfaction will be measured by a numeric (i.e., 1-5) rating scale (NRS)
Standardized Shoulder Questionnaire (Shoulder Q) Change
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.

Full Information

First Posted
March 18, 2017
Last Updated
January 5, 2021
Sponsor
Bioness Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03093935
Brief Title
StimRouter™ for Pain Management in Post-stroke Shoulder Pain
Acronym
PSSP
Official Title
StimRouter™ Neuromodulation System: Implanted Peripheral Nerve Stimulation for Pain Management When Treating Patients With Chronic Post-stroke Shoulder-pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of subject participation
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
November 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioness Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 Change in Worst Pain (BPI-SF3) Least Pain & Pain Right Now (BPI - SF 4,6) Patient Global Impression of Change (PGIC) Patient Satisfaction questionnaire 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Hemiplegic Shoulder Pain
Keywords
Post-Stroke, Neuromodulation, Axillary nerve, Peripheral Nerve Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort- Prospective, multi-center to collect population specific outcome measures in post-stroke patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
StimRouter Neuromodulation System
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
StimRouter Neuromodulation System
Other Intervention Name(s)
StimRouter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Inventory (BPI) Change
Description
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.
Time Frame
Change from Baseline at Month 3
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change (PGIC) Change
Description
Patient Global Impression of Change (PGIC) survey assesses perceived overall change in a combination of pain and life quality
Time Frame
Change from Baseline at Month 3
Title
Patient Satisfaction
Description
Patient Satisfaction will be measured by a numeric (i.e., 1-5) rating scale (NRS)
Time Frame
Month 3
Title
Standardized Shoulder Questionnaire (Shoulder Q) Change
Description
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.
Time Frame
Change from Baseline at Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith McBride
Organizational Affiliation
Bioness Inc
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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StimRouter™ for Pain Management in Post-stroke Shoulder Pain

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