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The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are:
Does EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline? Is EES a safe intervention for this patient population? Researchers will compare participants' motor function, sensory function, and quality of life assessments before EES implantation, immediately after activation of the device, and at 1, 3, and 6 months post-implantation to evaluate the longitudinal effects of EES.
Participants will:
Undergo surgical implantation of an EES device in the epidural space. Have the EES device activated and receive personalized stimulation parameter adjustments during follow-up visits.
Complete regular motor and sensory function 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 specified follow-up intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Electrical Stimulation (EES) + Standard Rehabilitation | Experimental | Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Electrical Stimulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| WISCI II (Walking Index for Spinal Cord Injury II) | 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. | baseline, and 1, 3, 6 monthes after surgery |
| Functional Independence Measure (FIM) | 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 | baseline, and 1, 3, 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) | ISNCSCI is the most authoritative and widely used standard for evaluating neurological function after spinal cord injury, comprising: Motor Scores: Range: Upper limbs (C5-T1): 0-25 per limb (total 0-50) Lower limbs (L2-S1): 0-25 per limb (total 0-50) Total motor score: 0-100 points Higher scores indicate better motor function Sensory Scores: Light touch: 0-2 points per dermatome (C2-S4/5) Total: 0-112 points Pinprick: 0-2 points per dermatome (C2-S4/5) Total: 0-112 points Interpretation: Higher scores indicate better sensory preservation Neurological Level of Injury Determined by the most caudal segment with: ≥3/5 muscle strength (motor level) Intact sensation (sensory level) ASIA Impairment Scale (AIS) Grading: A = Complete (no motor/sensory function in S4-S5) B = Sensory incomplete C = Motor incomplete (<50% key muscles ≥3/5 below NLI) D = Motor incomplete (≥50% key muscles ≥3/5 below NLI) E = Normal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junming Zhu, Chief Physician | Contact | 13968055768 | dr.zhujunming@zju.edu.cn | |
| Zhoule Zhu, Attending Physician | Contact | 15168377035 | doczhuzl@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junming Zhu, Chief Physician | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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One group of patients with spinal cord injury received EES treatment and 6 months of standardized rehabilitation therapy, while the other group received only standardized rehabilitation therapy.
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| Standard Rehabilitation Therapy | Procedure | 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. |
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| positron emission tomography-computed tomography (PET-CT) | Radiation | PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography. |
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| Diffusion Tensor Imaging (DTI) | Radiation | 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. |
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| Somatosensory Evoked Potentials (SEPs) | Procedure | 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. |
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| Motor Evoked Potentials (MEPs) | Procedure | 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. |
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| baseline, and 1, 3, 6 monthes after surgery |
| Modified Ashworth Scale | 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. | baseline, and 1, 3, 6 monthes after surgery |
| Penn | 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. | baseline, and 1, 3, 6 months after surgery |
| Hamilton Depression Rating Scale (HAMD) | 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. | baseline, and 1, 3, 6 monthes after surgery |
| Hamilton Anxiety Rating Scale (HAMA) | 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. | baseline, and 1, 3, 6 monthes after surgery |
| Visual Analog Scale (VAS) | 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. | baseline, and 1, 3, 6 monthes after surgery |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D056324 | Diffusion Tensor Imaging |
| D005073 | Evoked Potentials, Somatosensory |
| D019054 | Evoked Potentials, Motor |
| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D038524 | Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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