Epidural Electrical Stimulation in Spinal Cord Injury

Browse trials for

• Spinal Cord Injuries 1,948

Keywords

• Epidural Electrical Stimulation
• Spinal Cord Injuries
• Sensor function reconstruction
• Motor function reconstruction

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 10 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Study arms

• Experimental
  Epidural Electrical Stimulation (EES) + Standard Rehabilitation

  Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.

  Procedure: Epidural Electrical Stimulation · Procedure: Standard Rehabilitation Therapy · Radiation: positron emission tomography-computed tomography (PET-CT) · Radiation: Diffusion Tensor Imaging (DTI) · Procedure: Somatosensory Evoked Potentials (SEPs) · Procedure: Motor Evoked Potentials (MEPs)

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.

• Radiationpositron 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.

• 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.

• ProcedureSomatosensory 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.

• 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.

Primary outcomes

1. 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.

   Time frame: baseline, and 1, 3, 6 monthes after surgery

2. 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

   Time frame: baseline, and 1, 3, 6 months after surgery

Secondary outcomes

1. 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

   Time frame: baseline, and 1, 3, 6 monthes after surgery

2. 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.

   Time frame: baseline, and 1, 3, 6 monthes after surgery

3. 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.

   Time frame: baseline, and 1, 3, 6 months after surgery

4. 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.

   Time frame: baseline, and 1, 3, 6 monthes after surgery

5. 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.

   Time frame: baseline, and 1, 3, 6 monthes after surgery

6. 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.

   Time frame: baseline, and 1, 3, 6 monthes after surgery

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap