Spinal Cord Stimulation for Poststroke Spasticity

Summary

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

Conditions

• Spasticity Post Stroke

Interventions

DEVICE

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

DEVICE

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.

Sponsors & Collaborators

• China-Japan Friendship Hospital

  collaborator OTHER

• Beijing Sanbo Brain Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Beijing Tsinghua Changgeng Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Nanjing Brian Hospital

  collaborator OTHER

• Second Affiliated Hospital, Zhejiang University, School of Medicine

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Peking University Aerospace Center Hospital

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Beijing Pins Medical Co., Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-06

Primary Completion

2027-02-15

Completion

2027-05-31

Countries

• China

Study Locations