Spinal Cord Injuries (SCI)
Conditions
Keywords
Epidural Electrical Stimulation, Spinal Cord Injuries
Brief summary
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
PROCEDUREEpidural 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 neurological disorders.
PROCEDUREStandard 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.
PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography.
RADIATIONDiffusion 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.
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.
PROCEDUREMotor 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.
Sponsors
College of Biomedical Engineering and Instrumentation Science, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WISCI II (Walking Index for Spinal Cord Injury II) | baseline, and 1, 3, 6 monthes after surgery | The WISCI II evaluates walking ability in spinal cord injury patients. It has 21 levels (0-20), with scores based on mobility aids, assistance needed, and walking distance. A score of 0 means no walking; 20 indicates independent walking over 500 meters without aids. It tracks recovery progress and helps tailor rehabilitation plans for locomotor function. |
| Functional Independence Measure (FIM) | baseline, and 1, 3, 6 months after surgery | The Functional Independence Measure (FIM) is a widely used assessment tool designed to evaluate a person's functional status and level of independence in daily living activities, particularly among individuals with disabilities. FIM items are scored based on the level of assistance required to complete a task, ranging from 1 to 7 points per item. The FIM consists of 18 items across two domains: Motor domain (13 items): Includes activities such as eating, grooming, bathing, dressing, toileting, transfers (bed/chair, toilet, tub/shower), walking, and stair climbing. Cognitive domain (5 items): Covers communication (comprehension and expression) and social cognition (memory, problem-solving, and social interaction). The total score ranges from 18 to 126 points: ≤ 35 points: Severe dependence 36-89 points: Moderate dependence 90-119 points: Mild dependence 120-126 points: Functional independence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penn | baseline, and 1, 3, 6 months after surgery | The Penn Scale is a specific assessment tool for measuring muscle spasticity. Scores range from 0 (no spasticity) to 4 (severe, rigid spasticity), with higher scores indicating more intense muscle stiffness and involuntary contractions. |
| Hamilton Depression Rating Scale (HAMD) | baseline, and 1, 3, 6 monthes after surgery | The HAMD is a clinician-administered assessment used to measure the severity of depressive symptoms in individuals. It typically consists of 17 items, with scores based on the patient's reported feelings, behavior, and psychological state over the past week. A higher score indicates more severe depression. It is widely used to diagnose depression, evaluate treatment efficacy, and monitor symptom changes over time. |
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) | baseline, and 1, 3, 6 monthes after surgery | ISNCSCI is the most authoritative and widely used standard for evaluating neurological function after spinal cord injury, comprising: motor (0-100 points) and sensory (0-112 points) scores. Higher scores indicate better sensory preservation |
| Visual Analog Scale (VAS) | baseline, and 1, 3, 6 monthes after surgery | The VAS Pain Score is a self-reported measure of pain intensity. It consists of a 10-cm horizontal line, anchored by no pain (0) on one end and worst pain imaginable (10) on the other. Patients mark the line to represent their current pain level, and the score is determined by measuring the distance from no pain. It provides a simple, quick method to quantify subjective pain experiences, monitor fluctuations, and guide pain management strategies. |
| Hamilton Anxiety Rating Scale (HAMA) | baseline, and 1, 3, 6 monthes after surgery | The HAMA is a clinician-rated scale designed to quantify the severity of anxiety symptoms. It comprises 14 items, with scores reflecting both psychic anxiety (mental agitation) and somatic anxiety (physical complaints). A higher score signifies a greater level of anxiety. It assists in diagnosing anxiety disorders, assessing their intensity, and tracking the effectiveness of therapeutic interventions. |
| Modified Ashworth Scale | baseline, and 1, 3, 6 monthes after surgery | The Modified Ashworth Scale (MAS) is a clinical tool used to assess muscle spasticity by grading resistance during passive movement. It scores from 0 (no tone increase) to 4 (rigid joint), with intermediate grades: 1 (slight resistance), 1+ (mild resistance through ≤50% ROM), 2 (marked resistance), and 3 (considerable resistance). Higher MAS scores (max=4) indicate worse outcomes, reflecting more severe spasticity that impairs mobility. The assessment requires standardized passive stretching at 1 joint/sec. While widely used, it shows limitations in distinguishing mild/moderate spasticity reliably. |
Countries
China
Contacts
Primary ContactJunming Zhu
Backup ContactZhoule Zhu
Outcome results
None listed