Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury

Official title

Safety and Efficacy of Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury

Overview

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) combined with rehabilitation training for the reconstruction of walking in patients with chronic spinal cord injury (SCI) classified as AIS B-D. The main questions it aims to answer are: Does the intervention of EES combined with rehabilitation significantly improve walking capacity? Is the combined intervention a safe approach for this patient population? Researchers will compare participants' functional assessments before EES implantation and at 2, 4, 7, 10, and 13 months post-implantation to evaluate the longitudinal effects. The primary assessments include the Walking Index for Spinal Cord Injury II (WISCI II), the Spinal Cord Independence Measure (SCIM III), and the adverse event. Secondary outcome measures encompass the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), the Functional Independence Measure (FIM), the Modified Ashworth Scale (MAS), the Penn Spasm Frequency Scale, the 10-Meter Walk Test (10mWT), the 6-Minute Walk Test (6minWT), and pain Visual Analogue Scale (VAS) scores. Neurophysiological and imaging evaluations, including electromyography (EMG), motor evoked potentials (MEPs), somatosensory evoked potentials (SEPs), and positron emission tomography-computed tomography (PET-CT), will be conducted preoperatively and at 6 months postoperatively to explore the mechanisms of neuroplasticity. Participants will: Undergo surgical implantation of an EES device. Receive personalized EES parameter programming combined with rehabilitation training (≥2 hours daily) post-operatively. Complete a series of standardized functional and clinical outcome assessments at scheduled follow-up intervals. Undergo scheduled neurophysiological and metabolic imaging studies. Report any adverse events throughout the study duration.

Interventions

• Procedure Epidural spinal cord stimulation
  Epidural spinal cord stimulation is a medical technology that involves delivering controlled electrical impulses to the spinal cord through electrodes implanted in the epidural space-the area between the outermost membrane of the spinal cord (dura mater) and the vertebrae. This technique aims to modulate the activity of spinal neural networks, thereby regulating neurological functions and promoting functional recovery, particularly in individuals with spinal cord injuries or certain neurological
• Procedure Rehabilitation Therapy
  A structured, multidisciplinary rehabilitation program designed to improve motor function, mobility, and independence in participants with paralysis. The therapy typically includes physical Therapy and occupational Therapy.
• Radiation positron emission tomography-computed tomography (PET-CT)
  PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography.
• Procedure Somatosensory Evoked Potentials (SEPs)
  SEPs are electrophysiological responses recorded from the central or peripheral nervous system following electrical stimulation of sensory nerves. They assess the functional integrity of somatosensory pathways.
• Procedure Motor Evoked Potentials (MEPs)
  MEPs are electrophysiological responses elicited by transcranial magnetic stimulation or electrical stimulation of the motor cortex, recorded from peripheral muscles or the spinal cord. They evaluate the integrity of corticospinal tracts.
• Radiation Diffusion Tensor Imaging (DTI)
  DTI is an advanced MRI technique that maps white matter tracts by measuring the directionality (anisotropy) and magnitude of water molecule diffusion in neural tissues. It provides quantitative metrics of fibers.

Primary outcome measures

• Adverse Events (AEs) [Time frame: Entire study period from implantation to the 13-month postoperative follow-up.]
• WISCI II (Walking Index for Spinal Cord Injury II) [Time frame: baseline, and 2, 4, 7, 13 monthes after surgery.]
• Spinal Cord Independence Measure III (SCIM III) [Time frame: baseline, and 2, 4, 7, 13 months after surgery]

Secondary outcome measures (7)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [Time frame: baseline, and 2, 4, 7, 13 monthes after surgery]
• Functional Independence Measure (FIM) [Time frame: baseline, and 2, 4, 7, 13 months after surgery]
• The 10-Meter Walk Test (10m-WT) [Time frame: baseline, and 2, 4, 7, 10, 13 monthes after surgery]
• The 6-Minute Walk Test (6min-WT) [Time frame: baseline, and 2, 4, 7, 10, 13 monthes after surgery]
• Modified Ashworth Scale (MAS) [Time frame: baseline, and 2, 4, 7, 13 monthes after surgery]
• Penn [Time frame: baseline, and 2, 4, 7, 13 months after surgery]
• Visual Analog Scale (VAS) Pain Score [Time frame: baseline, and 2, 4, 7, 13 monthes after surgery]

Eligibility criteria

Inclusion criteria

• Age between 16 and 70 years.
• Diagnosed with traumatic spinal cord injury for ≥ 6 months and ≤ 60 months.
• American Spinal Injury Association Impairment Scale (AIS) grade B-D.
• Spinal cord injury level above T10;
• Walking Index for Spinal Cord Injury II (WISCI II) score ≤ 13.
• Completion of a standard conventional rehabilitation program prior to enrollment.
• Preserved upper limb function sufficient for self-propelling a manual wheelchair.
• Sitting balance grade ≥ 1.
• Ability to elicit clear electromyographic responses in lower limb muscles (e.g., rectus femoris, biceps femoris, gastrocnemius, tibialis anterior) upon transcutaneous electrical spinal cord stimulation at the T12-L1 vertebral levels.
• Willingness to voluntarily participate, and commitment to compliance with all necessary postoperative rehabilitation, assessments, and follow-up visits.

Exclusion criteria

• History of myocardial infarction or stroke within the past 6 months.
• Diagnosis of psychiatric disorders with active suicidal ideation or risk.
• Current pregnancy or planned pregnancy during the study period.
• Bleeding tendency or coagulopathy (prothrombin time ≥18 seconds).
• History of alcohol or substance abuse or dependence.
• Intellectual disability, cognitive impairment, or personality disorders.
• Other chronic medical conditions that may interfere with rehabilitation (e.g., unhealed severe fractures, hepatic or renal failure, severe anemia, etc.).
• Implantation of cardiac pacemakers, cardioverters, or defibrillators.
• Any other condition deemed inappropriate for participation by the investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT07306052 · 2025-1940

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗