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Spinal Cord Stimulation for Poststroke Spasticity (SCS-PSS)

2026年7月29日 更新者：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

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

92

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 中国
      • Beijing、中国
        • China-Japan Friendship Hospital
        • コンタクト：
          • Qi Wang
          • 電話番号：15810619158

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：SCS Group
Active SCS
デバイス：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
アクティブコンパレータ：Control Group
Sham SCS
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Mean Modified Ashworth Scale Score of the Primary Target Muscle Groups From Baseline to Week 6
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Modified Ashworth Scale Scores of the Primary Target Muscle Groups From Baseline
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Beijing Pins Medical Co., Ltd

協力者

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月6日

一次修了 (推定)

2027年2月15日

研究の完了 (推定)

2027年5月31日

試験登録日

最初に提出

2026年7月29日

QC基準を満たした最初の提出物

2026年7月29日

最初の投稿 (実際)

2026年8月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月4日

QC基準を満たした最後の更新が送信されました

2026年7月29日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SCS-PNS0102&PINS-C2-01-53

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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