Epidural Electrical Stimulation in Spinal Cord Injury (T11-L3)

Официальное название

Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury (T11-L3)

Обзор

The primary objective of this clinical trial is to investigate the efficacy of Epidural Electrical Stimulation (EES) in restoring motor and sensory function in patients with chronic spinal cord injury (SCI) at levels T11-L3, classified as ASIA B-D. The study aims to address the following key questions: Does EES lead to significant improvement in motor and sensory function compared to baseline in this patient population? To assess the longitudinal effects of EES, researchers will compare participants' motor function, sensory function, and quality of life measures at multiple time points: prior to EES implantation, immediately after device activation, and at 1, 3, and 6 months post-implantation. Participants will be required to:Undergo surgical implantation of an EES device in the epidural space. Have the device activated and receive individualized stimulation parameter adjustments during follow-up visits. Complete regular motor and sensory assessments using standardized protocols. Participate in structured rehabilitation training sessions while using the EES device. Report any adverse events and complete quality-of-life questionnaires at predetermined intervals.

Вмешательства

• Процедура Epidural Electrical Stimulation
  Epidural Electrical Stimulation (EES) 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 neurolo
• Процедура Standard 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.
• 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.
• 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.

Первичные конечные точки

• WISCI II (Walking Index for Spinal Cord Injury II) [Срок оценки: baseline, and 1, 3, 6 monthes after surgery]
• Functional Independence Measure (FIM) [Срок оценки: baseline, and 1, 3, 6 months after surgery]

Вторичные конечные точки (6)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [Срок оценки: baseline, and 1, 3, 6 monthes after surgery]
• Modified Ashworth Scale [Срок оценки: baseline, and 1, 3, 6 monthes after surgery]
• Penn [Срок оценки: baseline, and 1, 3, 6 months after surgery]
• Hamilton Depression Rating Scale (HAMD) [Срок оценки: baseline, and 1, 3, 6 monthes after surgery]
• Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: baseline, and 1, 3, 6 monthes after surgery]
• Visual Analog Scale (VAS) [Срок оценки: baseline, and 1, 3, 6 monthes after surgery]

Критерии участия

Критерии включения

• Spinal Cord Injury, ASIA B-D;
• Spinal cord injury levels at T11-L3;
• Diagnosed with spinal cord injury for ≥ 2 months and ≤ 24 months;
• WISCI II score < 13;
• An expected survival period of ≥ 12 months.
• Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, cooperate with necessary postoperative rehabilitation training and tests, and assist in follow-up visits.

Критерии исключения

• Subjects with other severe organic neurological diseases, mental illnesses other than anxiety/depression.
• Subjects with hemorrhagic diathesis or coagulation dysfunction (prothrombin time \[PT\] ≥ 18 seconds).
• Subjects with a history of alcohol or drug abuse or dependence.
• Subjects with mental retardation, cognitive dysfunction, or personality disorders.
• Subjects with a history of electroconvulsive therapy or those requiring continuous electrotherapy.
• Subjects with implanted cardiac pacemakers, cardioverters, or defibrillators. Expected survival period < 1 year.

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: NCT07207798 · 2025-0252

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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