An interventional study of Active spinal cord stimulation and Sham spinal cord stimulation in Spasticity Post Stroke, sponsored by Beijing Pins Medical Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Beijing Pins Medical Co., Ltd · Not applicable, Interventional, and Treatment
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:
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:
Post-stroke spasticity is a common disabling complication of ischemic or hemorrhagic stroke. It can lead to abnormal muscle tone, restricted joint movement, impaired motor function, pain, and reduced independence in daily activities. Current treatments include rehabilitation therapy, oral antispastic medications, and botulinum toxin injections, but some patients continue to have clinically significant spasticity despite these treatments. Spinal cord stimulation (SCS) is a neuromodulation technique that delivers electrical stimulation to the spinal cord and may help regulate abnormal spinal motor circuits and reduce spasticity.
Previous exploratory studies have suggested that SCS may reduce limb spasticity and improve muscle strength, motor coordination, and functional movement after stroke. However, the available evidence is mainly based on small or exploratory studies, and the safety and efficacy of SCS for post-stroke spasticity have not yet been confirmed in a large, randomized, sham-controlled clinical trial. Therefore, a well-designed controlled study is needed to determine whether the observed improvements are caused by active SCS and to further evaluate device-related safety.
The Spinal Cord Stimulation for Post-Stroke Spasticity study (SCS-PSS study) is a prospective, multicenter, double-blind, randomized, sham-controlled clinical trial designed to evaluate the safety and efficacy of an implanted SCS system for adults with post-stroke spasticity. The study will enroll 92 participants with stable unilateral upper- or lower-limb spasticity after ischemic or hemorrhagic stroke who have not achieved their treatment goals with previous treatments. All participants will undergo implantation of an SCS system and will then be randomized in a 1:1 ratio to receive either active SCS or sham SCS during the first 6 weeks after randomization. Participants will attend a postoperative visit within 3 to 7 days for active or sham device activation, programming, safety assessment, and study evaluations. At 6 weeks after randomization, all participants will receive active stimulation and will continue follow-up through 24 weeks. In addition, they will undergo long-term follow-up for up to 2 years to further evaluate the durability of treatment effects and the long-term safety of the implanted SCS system. The primary outcome is the change from baseline to 6 weeks after randomization in the mean Modified Ashworth Scale score of primary target muscle groups. Additional outcomes include joint range of motion, motor function, walking ability, functional independence, pain, quality of life, adverse events, serious adverse events, and device deficiencies.
621 studies on the registry are indexed under Muscle Spasticity; 127 are open to participants now.
This study's planned enrollment of 92 is above the median of 36 across 472 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Beijing Pins Medical Co., Ltd is the lead sponsor of 31 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active SCS
Device: Active spinal cord stimulation
Sham SCS
Device: Sham 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
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.
Change in Mean Modified Ashworth Scale Score of the Primary Target Muscle Groups From Baseline to Week 6
The primary outcome is the change in the mean Modified Ashworth Scale (MAS) score of the Primary Target Muscle Groups from baseline to Week 6. The Primary Target Muscle Groups are selected from a upper or lower limb before treatment and must include at least two muscle groups. For the upper limb, eligible muscle groups include the shoulder adductors, shoulder internal rotators, elbow flexors, elbow extensors, forearm pronators, wrist flexors, and finger flexors. For the lower limb, eligible muscle groups include the hip flexors, hip adductors, hip internal rotators, knee flexors, knee extensors, and ankle plantar flexors. For analysis, the original MAS grades are converted to a 0-5 numerical scale, with grade 1+ converted to 2 and grades 2, 3, and 4 converted to 3, 4, and 5, respectively. The mean MAS score is calculated across the selected Primary Target Muscle Groups. Change is calculated as the Week 6 mean MAS score minus the baseline mean MAS score.
Time frame: Baseline to Week 6 after randomization
Change in Modified Ashworth Scale Scores of the Primary Target Muscle Groups From Baseline
Change in MAS of the primary target muscle groups from baseline to day 0, week 6, week 12, week 24, 1 year and 2 years after randomization
Time frame: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Proportion of Participants With an Improvement in Mean Modified Ashworth Scale Score of at Least 1 Point
A participant is defined as a responder when the mean MAS score of the Primary Target Muscle Groups decreases by at least 1 point compared with baseline. The outcome is reported as the proportion of responders at each assessment.
Time frame: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in Active and Passive Joint Range of Motion From Baseline
Active and passive range of motion are measured in degrees for movements corresponding to the assessed muscle groups. Upper-limb measurements include shoulder abduction, shoulder external rotation, elbow extension, elbow flexion, forearm supination, wrist extension, and metacarpophalangeal joint extension. Lower-limb measurements include hip extension, hip abduction, hip external rotation, knee extension, knee flexion, and ankle dorsiflexion. A greater range generally indicates better joint mobility.
Time frame: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in Fugl-Meyer Assessment Score From Baseline
The Fugl-Meyer Assessment (FMA) is used to assess motor and sensory function. The upper-limb motor score ranges from 0 to 66, and the lower-limb motor score ranges from 0 to 34. Light touch sensation is assessed at the upper arm, palm, thigh, and sole, with each site scored from 0 to 2, giving a total score of 0 to 8. Proprioception is assessed at the shoulder, elbow, wrist, thumb, hip, knee, ankle, and toe joints, with each site scored from 0 to 2, giving a total score of 0 to 16. Higher scores indicate better motor and sensory function.
Time frame: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in Functional Independence Measure Score From Baseline
The Functional Independence Measure (FIM) is used to assess functional independence. The change in total FIM score from baseline is calculated at each post-baseline assessment. A higher score indicates greater functional independence
Time frame: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in Physician Global Assessment Score From Baseline
The Physician Global Assessment (PGA) is completed by the investigator to assess overall spasticity severity and treatment response. The PGA score is recorded at each post-baseline assessment.
Time frame: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in 10-Meter Walk Test Performance From Baseline
The 10-Meter Walk Test (10MWT) is used to assess comfortable and fast walking speed. The change in walking time and walking speed from baseline is calculated at each post-baseline assessment. A shorter walking time or higher walking speed indicates better walking performance.
Time frame: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in EQ-5D-5L Score From Baseline
The EQ-5D-5L is used to assess health-related quality of life. The change in the EQ-5D-5L health utility index and EQ-VAS score from baseline is calculated at each post-baseline assessment. Higher scores indicate better health status.
Time frame: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in Visual Analogue Scale Score From Baseline
Spasticity-related pain is assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10. The change in VAS score from baseline is calculated at each post-baseline assessment. A lower score indicates less pain.
Time frame: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Plan to share: Undecided
Started Sep 2026 (actual). Primary completion is estimated for Feb 2027, 5 months after the start.
Of 234 interventional studies with no phase under Muscle Spasticity, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 5 months is below that.
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