About this trial
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
Eligibility criteria
Qualifiers
Aged ≥18 years and <75 years, regardless of sex;
Diagnosed with ischemic or hemorrhagic stroke, with unilateral or single-limb motor dysfunction persisting for at least 6 months;
The primary brain lesion and its underlying cause are clinically stable;
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;
Disqualifiers
Any contraindication to spinal cord stimulation surgery;
Uncontrolled refractory epilepsy;
Presence of tonic spasticity, such as decorticate rigidity or decerebrate rigidity;
Poorly controlled severe psychiatric or cognitive impairment, defined as a Beck Depression Inventory-II score >25 or a Mini-Mental State Examination score <24;
Trial design
Treatments tested in this trial
- Active spinal cord stimulation
- Sham spinal cord stimulation
Treatment groups
Sponsors and collaborators
Beijing Pins Medical Co., Ltd
Lead sponsor
China-Japan Friendship Hospital
Collaborator
Beijing Sanbo Brain Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Beijing Tiantan Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
Beijing Tsinghua Changgeng Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
West China Hospital
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
RenJi Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Nanjing Brian Hospital
Collaborator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Peking University Aerospace Center Hospital
Collaborator
Anhui Provincial Hospital
Collaborator