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Spinal Cord Stimulation for Poststroke Spasticity (SCS-PSS)

29 lipca 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

92

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Chiny
      • Beijing, Chiny
        • China-Japan Friendship Hospital
        • Kontakt:
          • Qi Wang
          • Numer telefonu: 15810619158

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: SCS Group
Active SCS
Urządzenie: 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
Aktywny komparator: Control Group
Sham SCS
Urządzenie: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Mean Modified Ashworth Scale Score of the Primary Target Muscle Groups From Baseline to Week 6
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Modified Ashworth Scale Scores of the Primary Target Muscle Groups From Baseline
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Beijing Pins Medical Co., Ltd

Współpracownicy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

6 sierpnia 2026

Zakończenie podstawowe (Szacowany)

15 lutego 2027

Ukończenie studiów (Szacowany)

31 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

29 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 lipca 2026

Pierwszy wysłany (Rzeczywisty)

4 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SCS-PNS0102&PINS-C2-01-53

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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