Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury

NCT07306052 | Recruiting

• 1 other identifier: 2025-1940
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) combined with rehabilitation training for the reconstruction of walking in patients with chronic spinal cord injury (SCI) classified as AIS C-D. The main questions it aims to answer are: Does the intervention of EES combined with rehabilitation significantly improve walking capacity? Is the combined intervention a safe approach for this patient population? Researchers will compare participants' functional assessments before EES implantation and at 1, 3, 6, 9, and 12 months post-implantation to evaluate the longitudinal effects. The primary assessments include the Walking Index for Spinal Cord Injury II (WISCI II), the 10-Meter Walk Test (10mWT), and the 6-Minute Walk Test (6minWT). Secondary outcome measures encompass the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), the Spinal Cord Independence Measure (SCIM III), the Functional Independence Measure (FIM), the Modified Ashworth Scale (MAS), the Penn Spasm Frequency Scale, and pain Visual Analogue Scale (VAS) scores. Neurophysiological and imaging evaluations, including electromyography (EMG), motor evoked potentials (MEPs), somatosensory evoked potentials (SEPs), and positron emission tomography-computed tomography (PET-CT), will be conducted preoperatively and at 6 months postoperatively to explore the mechanisms of neuroplasticity. Participants will: Undergo surgical implantation of an EES device. Receive personalized EES parameter programming combined with rehabilitation training (≥2 hours daily) post-operatively. Complete a series of standardized functional and clinical outcome assessments at scheduled follow-up intervals. Undergo scheduled neurophysiological and metabolic imaging studies. Report any adverse events throughout the study duration.

Conditions

Spinal Cord Injuries (SCI)

Keywords

Epidural Electrical Stimulation; Spincal cord stimulation; Spincal cord injury

Outcome Measures

Primary Outcomes (3)

• Adverse Events (AEs)

  The incidence, severity, and relationship to the intervention of all AEs . All AEs will be defined, recorded, and graded according to the International Council for Harmonisation Good Clinical Practice guidelines. Serious adverse events will be reported specifically based on established criteria. This assessment will comprehensively cover all safety concerns related to the surgical procedure (epidural stimulator implantation), the electrical stimulation itself (across various parameter sets).

  Entire study period from implantation to the 13-month postoperative follow-up.

• 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 and assistance needed. A score of 0 means no walking; 20 indicates independent walking without aids.

  baseline, and 2, 4, 7, 13 monthes after surgery.

• Spinal Cord Independence Measure III (SCIM III)

  SCIM III is a disease-specific, validated assessment tool designed to evaluate the functional independence of individuals with spinal cord injury in performing essential activities of daily living, self-care, mobility, and respiration/management. It is tailored to reflect the unique challenges and priorities of the SCI population. The SCIM III consists of 19 items across three subscales: Self-care subscale (0-20 points): Includes feeding, grooming, bathing, and dressing. Respiration and sphincter management subscale (0-40 points): Covers respiration, bladder management, and bowel management. Mobility subscale (0-40 points): Assesses mobility in room and toilet, indoors and outdoors mobility, and stair management. The total score ranges from 0 to 100 points, with higher scores indicating greater functional independence.

  baseline, and 2, 4, 7, 13 months after surgery

Secondary Outcomes (7)

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

  baseline, and 2, 4, 7, 13 monthes after surgery

• Functional Independence Measure (FIM)

  baseline, and 2, 4, 7, 13 months after surgery

• The 10-Meter Walk Test (10m-WT)

  baseline, and 2, 4, 7, 10, 13 monthes after surgery

• The 6-Minute Walk Test (6min-WT)

  baseline, and 2, 4, 7, 10, 13 monthes after surgery

• Modified Ashworth Scale (MAS)

  baseline, and 2, 4, 7, 13 monthes after surgery

Other Outcomes (4)

• Surface Electromyography (EMG)

  baseline, and 7 monthes after surgery

• Motor Evoked Potentials (MEPs)

  baseline, and 7 monthes after surgery

• Somatosensory Evoked Potentials (SEPs)

  baseline, and 7 monthes after surgery

Study Arms (1)

Epidural spinal cord stimulation + Standard Rehabilitation

EXPERIMENTAL

Participants receive the epidural spnial cord stimulation combined with individualized standard rehabilitation therapy for 12 months.

Procedure: Epidural spinal cord stimulation; Procedure: Rehabilitation Therapy; Radiation: positron emission tomography-computed tomography (PET-CT); Procedure: Somatosensory Evoked Potentials (SEPs); Procedure: Motor Evoked Potentials (MEPs); Radiation: Diffusion Tensor Imaging (DTI)

Interventions

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 spinal cord stimulation + Standard Rehabilitation

Epidural spinal cord stimulation PROCEDURE

Epidural spinal cord stimulation 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 spinal cord stimulation + Standard Rehabilitation

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 spinal cord stimulation + 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 spinal cord stimulation + 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 spinal cord stimulation + 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 spinal cord stimulation + 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:

• Age between 16 and 65 years.
• Diagnosed with traumatic spinal cord injury for ≥ 6 months and ≤ 36 months.
• American Spinal Injury Association Impairment Scale (AIS) grade C-D.
• Spinal cord injury level above T10;
• Walking Index for Spinal Cord Injury II (WISCI II) score \< 13.
• Completion of a standard conventional rehabilitation program prior to enrollment.
• Preserved upper limb function sufficient for self-propelling a manual wheelchair.
• Sitting balance grade ≥ 1.
• Ability to elicit clear electromyographic responses in lower limb muscles (e.g., rectus femoris, biceps femoris, gastrocnemius, tibialis anterior) upon transcutaneous electrical spinal cord stimulation at the T12-L1 vertebral levels.
• Willingness to voluntarily participate, and commitment to compliance with all necessary postoperative rehabilitation, assessments, and follow-up visits.

You may not qualify if:

• History of myocardial infarction or stroke within the past 6 months.
• Diagnosis of psychiatric disorders with active suicidal ideation or risk.
• Current pregnancy or planned pregnancy during the study period.
• Bleeding tendency or coagulopathy (prothrombin time ≥18 seconds).
• History of alcohol or substance abuse or dependence.
• Intellectual disability, cognitive impairment, or personality disorders.
• Other chronic medical conditions that may interfere with rehabilitation (e.g., unhealed severe fractures, hepatic or renal failure, severe anemia, etc.).
• Implantation of cardiac pacemakers, cardioverters, or defibrillators.
• Any other condition deemed inappropriate for participation by the investigators.

Sponsors & Collaborators

• Zhejiang University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

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

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Junming Zhu

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junming Zhu, Chief Physician

CONTACT

0571-87784716; dr.zhujunming@zju.edu.cn

Zhoule Zhu, Attending Physician

CONTACT

0571-87784716; 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: December 12, 2025
• First Posted: December 29, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

CN (1)