Spinal Cord Stimulation for Poststroke Spasticity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Pins Medical Co., Ltd

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

92 Participants
are divided into 2 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