Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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.
• Лучевая терапия 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.
• Процедура 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.
• Процедура 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.
• Лучевая терапия 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.

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07306052 · 2025-1940

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗