NCT07744659Recruiting
Spinal Cord Stimulation for Poststroke Spasticity
Spinal Cord Stimulation for Poststroke Spasticity: a Multicentre, Double-blind, Randomised, Sham-controlled Trial (SCS-PSS)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn whether spinal cord stimulation (SCS) is effective in treating post-stroke spasticity in adults. It will also evaluate the safety of the implanted SCS system. The main questions it aims to answer are: 1. Does active SCS reduce limb spasticity compared with sham stimulation? 2. What device-related problems do participants experience during the study? All participants receive the same implantation and programming procedures,but no therapeutic stimulation(0 mA) for sham SCS group duringthe first 6 weeks after randomization. Participants will: 1. Have an SCS system surgically implanted 2. Be randomly assigned to receive active SCS or sham SCS for 6 weeks 3. After completion of the 6-week randomized comparison period, active stimulation will be initiated for all participants. 4. Attend a post-operative visit within 3 to 7 days after surgery for device activation or sham activation, programming, safety checks, and study assessments 5. Attend follow-up visits for study assessments at approximately 6, 12, 24 weeks, 1 year and 2 years after randomization 6. Complete assessments of muscle spasticity, joint range of motion, motor function, walking ability, daily functioning, pain, and quality of life 7. Report any medical problems or device-related problems during the study
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 29 Jul 2026
- Start date
- 9 Sept 2026
- Primary completion date
- 15 Feb 2027
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Diseases
- Stroke
- NCT number
- NCT07744659
What you commit to
- Study type: Interventional
- Planned participants: 92
- From 9 Sept 2026 to the primary completion date, 15 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contraindication to spinal cord stimulation surgery;
- Presence of an implanted neurostimulator or drug delivery system;
- Botulinum toxin treatment within 4 months before enrollment;
- 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;
- Participation in another clinical study within 4 weeks before signing informed consent;
Other illness
- Uncontrolled refractory epilepsy;
- Poorly controlled severe psychiatric or cognitive impairment, defined as a Beck Depression Inventory-II score \>25 or a Mini-Mental State Examination score \<24;
- Active systemic infection;
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
Other
- Presence of tonic spasticity, such as decorticate rigidity or decerebrate rigidity;
- Pregnancy, breastfeeding, or planned pregnancy during the study;
- The participant or family is unable or unwilling to participate in long-term SCS treatment management;
Who the study is looking for
- Aged ≥18 years and \<75 years, regardless of sex;
- Diagnosed with ischemic or hemorrhagic stroke, with unilateral or single-limb motor dysfunction persisting for at least 6 months;
- The primary brain lesion and its underlying cause are clinically stable;
- 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;
- 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;
- The type and dose of existing rehabilitation therapy and oral antispastic medications must remain unchanged during the study;
- Willing and able to complete all study visits and procedures;
- Able to understand the study and provide written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.