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

Official title

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

Overview

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.

Interventions

• Procedure 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
• Procedure 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.
• 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.
• 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.
• 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.

Primary outcome measures

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

Secondary outcome measures (6)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

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: NCT07207798 · 2025-0252

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗