Clinical Study of the Efficacy and Safety of Spinal Cord Stimulation in Patients With Limb Motor Dysfunction Following Stroke

Second Affiliated Hospital, Zhejiang University, School of Medicine6 enrolled

Overview

To assess the efficacy and safety of spinal cord stimulation in treating post-stroke limb motor disorders, we propose to conduct a clinical trial. This study seeks to accumulate additional clinical experience with spinal cord stimulation in patients suffering from post-stroke limb motor disorders and to enhance their quality of life.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Spinal cord stimulatorDEVICE

This trial is a single-arm, self-controlled exploratory clinical study. Participants will undergo surgical implantation of spinal cord stimulation electrodes and receive programming and optimization of spinal cord stimulation parameters.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Hemiparesis resulting from a single ischemic or hemorrhagic stroke, with a disease duration of ≥6 months. 2. Aged between 20 and 80 years (inclusive). 3. Received regular rehabilitation therapy after stroke but with poor recovery of limb motor function; Fugl-Meyer Assessment upper extremity score \>7 and \<45, and lower extremity score \>5 and \<30. 4. Partially preserved sensory function. Exclusion Criteria: 1. Severe systemic diseases (e.g., neurological disorders other than stroke, cancer, severe circulatory or respiratory diseases, liver or kidney failure, etc.) or other conditions that may impair the subject's motor or cognitive function. 2. Presence of spinal cord-related nerve compression that could cause severe functional impairment. 3. Women who are pregnant or breastfeeding. 4. Use of anticoagulant, antiplatelet, antispasmodic, or antiepileptic medications prior to enrollment or during the study period. 5. Severe joint contracture that, in the clinical investigator's opinion, precludes participation in the study. 6. Severe mental illness or intellectual disability that prevents cooperation with treatment or follow-up questionnaires, with a Mini-Mental State Examination (MMSE) score \<24. 7. Presence of other implanted medical devices. 8. Severe claustrophobia.

Locations (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Fugl-Meyer Assessment (FMA)

Time frame: One year

Secondary Outcomes

Active and passive range of motion (A/PROM)

Time frame: One year

Surface electromyography (sEMG):Mean amplitude

Mean surface electromyography (sEMG) amplitude, measured in microvolts (µV), will be derived from recordings of lower-limb muscles, including the tibialis anterior, gastrocnemius, quadriceps femoris, and biceps femoris. Recordings will be obtained during standardized lower-limb motor tasks or voluntary muscle contractions. Measurements will be analyzed separately for each muscle and, where applicable, for each side. This parameter will be used to assess changes in lower-limb muscle activation after spinal cord stimulation. Higher values indicate greater muscle activation.

Time frame: One year

Modified Ashworth Scale (MAS)

The Modified Ashworth Scale (MAS) will be used to assess muscle tone and spasticity in lower-limb muscle groups, including hip flexors, hip extensors, hip adductors, hip abductors, knee flexors, knee extensors, ankle plantar flexors, and ankle dorsiflexors. MAS grades range from 0 to 4, with an additional intermediate grade of 1+. For statistical analysis, MAS grades may be converted to a 0-5 ordinal score, where 0 indicates no increase in muscle tone and 5 indicates that the affected limb is rigid in flexion or extension. Higher scores indicate greater muscle tone and more severe spasticity. Scores will be assessed separately for each side and compared across baseline and follow-up assessments.

Time frame: One year

TMS-MEP:Amplitude and Waveform morphology

Motor evoked potential (MEP) amplitude and waveform morphology will be assessed from transcranial magnetic stimulation-induced MEP recordings of lower-limb muscles, including the tibialis anterior, gastrocnemius, quadriceps femoris, and biceps femoris. MEP amplitude will be measured as the peak-to-peak amplitude, measured in microvolts (µV) or millivolts (mV), according to the study protocol. The presence, reproducibility, and morphology of the MEP waveform will also be evaluated. Measurements will be analyzed separately for each muscle and, where applicable, for each side. These parameters will be used to evaluate changes in corticospinal excitability and motor pathway function after spinal cord stimulation.

Central Contacts

Gao Chen

CONTACT

0571-87784713 d.chengao@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.