Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT03093935
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03093935
Study Brief:
Protocol Section:
NCT03093935