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A single-arm, prospective, single-center preliminary clinical study on spinal cord stimulation for hemiplegic spasticity after stroke

A single-arm, prospective, single-center preliminary clinical study on spinal cord stimulation for hemiplegic spasticity after stroke

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101316
Enrollment
Unknown
Registered
2025-04-23
Start date
2025-04-23
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemiplegic spasticity after stroke

Interventions

Spinal Cord Stimulation (SCS) group:Spinal Cord Stimulation

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 75 years; 2.A history of a single ischemic or hemorrhagic stroke leading to hemiplegia for more than 6 months (previous strokes that did not result in limb spasticity are excluded); 3.Patients who have not responded to previous systematic rehabilitation therapy; 4.A Modified Ashworth Scale (MAS) score of >= Grade I for the main affected joint of the limb; 5.The research participant or their legal representative has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe illness or medical conditions (including but not limited to cancer, severe cardiac or respiratory diseases, renal failure, and other neurological disorders); 2. Pregnancy or lactation; 3. Receiving antiepileptic drug treatment throughout the study period; 4. No botulinum toxin injection treatment within the past 6 months; 5. Presence of any implanted medical devices; 6. Severe claustrophobia; 7. The clinical physician/investigator considers the joint contracture to be too severe to participate in the study activities; 8. Unwillingness to undergo treatment or follow-up evaluations; 9. Participation in other clinical trials within 3 months prior to enrollment in this clinical trial; 10. Any other conditions deemed by the investigator as unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Asworth score;

Secondary

MeasureTime frame
Brunnstrom;Assessment of Hemiplegic Hand Function Grading;H-reflex;Brief Pain Inventory;Fugl-Meyer Assessment of Motor Function;Berg Balance Scale;Walking speed 10-m ;EuroQol 5-Dimensions;Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;Pittsburgh sleep quality index;Pittsburgh Sleep Quality Index;Resting-State Functional Magnetic Resonance Imaging;Diffusion Tensor Imaging;Brain Metabolic Tomography;

Countries

China

Contacts

Public ContactZhu Hongwei

Xuanwu Hospital Capital Medical University

zhuhongwei@xwh.ccmu.edu.cn+86 136 6134 9255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026