Spinal cord stimulation to help post-stroke spasticity
Official title: Spinal Cord Stimulation for Poststroke Spasticity: a Multicentre, Double-blind, Randomised, Sham-controlled Trial (SCS-PSS)
Run by Beijing Pins Medical Co., Ltd · NCT07744659 · Data updated 2026-11-12
This study tests whether active spinal cord stimulation can reduce limb spasticity after stroke compared with a sham treatment in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | Beijing Pins Medical Co., Ltd Industry-sponsored |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | September 9, 2026 |
| Main results expected | February 15, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07744659 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 to 74 with unilateral post-stroke spasticity (MAS ≥2 in ≥2 muscle groups) persisting for at least 6 months despite other treatments.
✕Probably not a fit
Individuals whose spasticity is not responsive to neuromodulation or who have contraindications to spinal cord surgery may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized, double-blind trial enrolls adults with persistent post-stroke limb spasticity to receive an implanted spinal cord stimulation (SCS) system. Participants are randomized to active SCS or sham stimulation for six weeks, after which all receive active stimulation. The study includes implant, programming, safety checks, and standardized follow-up assessments to evaluate spasticity outcomes and device-related safety. The goal is to determine if active SCS improves motor function and reduces spasticity beyond existing therapies, while monitoring any device-related complications. Prior evidence is promising but limited, highlighting the need for a rigorous sham-controlled design.
Why it matters
Potential benefit: If successful, participants could experience reduced limb spasticity and improved movement, potentially enhancing independence and quality of life.
How similar studies have gone: Previous exploratory studies suggested possible reductions in spasticity with SCS, but robust randomized evidence is lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged ≥18 years and \<75 years, regardless of sex; 2. Diagnosed with ischemic or hemorrhagic stroke, with unilateral or single-limb motor dysfunction persisting for at least 6 months; 3. The primary brain lesion and its underlying cause are clinically stable; 4. Presence of unilateral upper- or lower-limb spasticity, with a Modified Ashworth Scale (MAS) grade of ≥2 in at least two muscle groups of the affected limb; 5. Post-stroke limb dysfunction has not reached the treatment goal despite previous interventions, such as physical therapy and oral medications, and the participant's condition has shown no recent improvement; 6. The type and dose of existing rehabilitation therapy and oral antispastic medications must remain unchanged during the study; 7. Willing and able to complete all study visits and procedures; 8. Able to understand the study and provide written informed consent. Exclusion Criteria: 1. Any contraindication to spinal cord stimulation surgery; 2. Uncontrolled refractory epilepsy; 3. Presence of tonic spasticity, such as decorticate rigidity or decerebrate rigidity; 4. Poorly controlled severe psychiatric or cognitive impairment, defined as a Beck Depression Inventory-II score \>25 or a Mini-Mental State Examination score \<24; 5. Active systemic infection; 6. Presence of an implanted neurostimulator or drug delivery system; 7. Botulinum toxin treatment within 4 months before enrollment; 8. Plans to initiate any new treatment during the study that may affect limb movement, including chemical denervation therapies (such as botulinum toxin), oral antispastic medications, surgical procedures (such as peripheral neurotomy or contralateral C7 nerve transfer), or other physical therapy interventions; 9. Pregnancy, breastfeeding, or planned pregnancy during the study; 10. The participant or family is unable or unwilling to participate in long-term SCS treatment management; 11. Participation in another clinical study within 4 weeks before signing informed consent; 12. Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
Where it's running
-
China-Japan Friendship Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Jianguang Sun
- Email: sunjianguang@pinsmedical.com
- Phone: 010-60736388
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.