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

NCT07207798 | Recruiting DMC

• 1 other identifier: 2025-0252
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries (SCI)

Keywords

Epidural Electrical Stimulation; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

  baseline, and 1, 3, 6 monthes after surgery

• Modified Ashworth Scale

  baseline, and 1, 3, 6 monthes after surgery

• Penn

  baseline, and 1, 3, 6 months after surgery

• Hamilton Depression Rating Scale (HAMD)

  baseline, and 1, 3, 6 monthes after surgery

• Hamilton Anxiety Rating Scale (HAMA)

  baseline, and 1, 3, 6 monthes after surgery

Study Arms (1)

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.

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

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.

Epidural Electrical Stimulation (EES) + Standard Rehabilitation

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.

Epidural Electrical Stimulation (EES) + Standard Rehabilitation

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.

Epidural Electrical Stimulation (EES) + Standard Rehabilitation

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.

Epidural Electrical Stimulation (EES) + Standard Rehabilitation

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.

Epidural Electrical Stimulation (EES) + Standard Rehabilitation

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.

Epidural Electrical Stimulation (EES) + Standard Rehabilitation

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• College of Biomedical Engineering and Instrumentation Science, Zhejiang University: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Diffusion Tensor Imaging; Evoked Potentials, Somatosensory; Evoked Potentials, Motor

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Junming Zhu

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junming Zhu

CONTACT

13968055768; dr.zhujunming@zju.edu.cn

Zhoule Zhu

CONTACT

15168377035; doczhuzl@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: October 6, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)