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NCT Number: NCT07627516

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Gao Chen

CONTACT

[email protected]

0571-87784713

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemiparesis resulting from a single ischemic or hemorrhagic stroke, with a disease duration of ≥6 months.
  • Aged between 20 and 80 years (inclusive).
  • 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.
  • Partially preserved sensory function.

Exclusion criteria

  • 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.
  • Presence of spinal cord-related nerve compression that could cause severe functional impairment.
  • Women who are pregnant or breastfeeding.
  • Use of anticoagulant, antiplatelet, antispasmodic, or antiepileptic medications prior to enrollment or during the study period.
  • Severe joint contracture that, in the clinical investigator's opinion, precludes participation in the study.
  • Severe mental illness or intellectual disability that prevents cooperation with treatment or follow-up questionnaires, with a Mini-Mental State Examination (MMSE) score <24.
  • Presence of other implanted medical devices.
  • Severe claustrophobia.

Treatment and study plan

Spinal cord stimulator

Device

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.

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: One year

Secondary outcomes

  1. Active and passive range of motion (A/PROM)

    Time frame: One year

  2. Surface electromyography (sEMG):Mean amplitude

    Time frame: One year

    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.

  3. Modified Ashworth Scale (MAS)

    Time frame: One year

    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.

  4. TMS-MEP:Amplitude and Waveform morphology

    Time frame: One year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gao Chen

CONTACT

[email protected]

0571-87784713

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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