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NCT07744659

Spinal Cord Stimulation for Poststroke Spasticity

Sponsor: Beijing Pins Medical Co., Ltd

View on ClinicalTrials.gov

Summary

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

Official title: Spinal Cord Stimulation for Poststroke Spasticity: a Multicentre, Double-blind, Randomised, Sham-controlled Trial (SCS-PSS)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-06

Completion Date

2027-05-31

Last Updated

2026-08-04

Healthy Volunteers

Conditions

Spasticity Post Stroke

Interventions

DEVICE

Active spinal cord stimulation

Participants will receive therapeutic electrical stimulation through the implanted spinal cord stimulation system beginning on Day 0, defined as the day of active or sham activation within 3-7 days after surgery. An individualized SCS programming strategy will be used. Initial stimulation parameters will include a frequency of 40-60 Hz, a pulse width of 200-300 μs, and a low starting amplitude that will be gradually increased according to participant tolerance. For participants with concomitant conditions such as pain, the stimulation frequency may be increased as clinically appropriate. Intermittent stimulation will be preferred, and electrode contact combinations will be individually selected. Active stimulation will continue through the 24-week follow-up

DEVICE

Sham spinal cord stimulation

Participants will undergo the same implantation and programming procedures. On Day 0, the implanted system will be turned on, but the stimulation amplitude will be set to 0 mA so that no effective electrical stimulation is delivered during the 6-week randomized comparison period. After completion of the Week 6 assessment, participants will receive active SCS using the same individualized programming principles as the Active SCS Group. Active stimulation will continue through the 24-week follow-up.

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.

Locations (1)

China-Japan Friendship Hospital

Beijing, China