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

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• Stroke 7,286

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 6 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Study arms

• Experimental
  spinal cord stimulation group

  Device: Spinal cord stimulator

Interventions

• DeviceSpinal cord stimulator

  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

   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

3. 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

4. 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.

   Time frame: One year