Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Spinal Cord Stimulation for Poststroke Spasticity (SCS-PSS)

29. července 2026 aktualizováno: Beijing Pins Medical Co., Ltd

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

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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

92

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Čína
      • Beijing, Čína
        • China-Japan Friendship Hospital
        • Kontakt:
          • Qi Wang
          • Telefonní číslo: 15810619158

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: SCS Group
Active SCS
Přístroj: 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
Aktivní komparátor: Control Group
Sham SCS
Přístroj: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Mean Modified Ashworth Scale Score of the Primary Target Muscle Groups From Baseline to Week 6
Časové okno: Baseline to Week 6 after randomization

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.
Baseline to Week 6 after randomization

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Modified Ashworth Scale Scores of the Primary Target Muscle Groups From Baseline
Časové okno: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
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
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
Časové okno: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
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.
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
Časové okno: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
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.
Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in Fugl-Meyer Assessment Score From Baseline
Časové okno: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
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.
Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in Functional Independence Measure Score From Baseline
Časové okno: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
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
Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in Physician Global Assessment Score From Baseline
Časové okno: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
The Physician Global Assessment (PGA) is completed by the investigator to assess overall spasticity severity and treatment response. The change in PGA score from baseline is calculated at each post-baseline assessment.
Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in 10-Meter Walk Test Performance From Baseline
Časové okno: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
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.
Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in EQ-5D-5L Score From Baseline
Časové okno: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
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.
Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
Change in Visual Analogue Scale Score From Baseline
Časové okno: Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization
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.
Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Beijing Pins Medical Co., Ltd

Spolupracovníci

Xiangya Hospital of Central South University
Beijing Tiantan Hospital
First Affiliated Hospital, Sun Yat-Sen University
RenJi Hospital
West China Hospital
Qilu Hospital of Shandong University
Beijing Sanbo Brain Hospital
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
The First Affiliated Hospital of Zhengzhou University
China-Japan Friendship Hospital
First Affiliated Hospital of Xinjiang Medical University
Anhui Provincial Hospital
Beijing Tsinghua Changgeng Hospital
Nanjing Brian Hospital
Peking University Aerospace Center Hospital
Second Affiliated Hospital, Zhejiang University, School of Medicine

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

6. srpna 2026

Primární dokončení (Odhadovaný)

15. února 2027

Dokončení studie (Odhadovaný)

31. května 2027

Termíny zápisu do studia

První předloženo

29. července 2026

První předloženo, které splnilo kritéria kontroly kvality

29. července 2026

První zveřejněno (Aktuální)

4. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • SCS-PNS0102&PINS-C2-01-53

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit