Epidural Electrical Stimulation in Spinal Cord Injury

Zhejiang University

Status: Enrolling

Conditions: Spinal Cord Injuries (SCI)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07105878

2025-1040

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spinal Cord Injury, ASIA B-D;
• Spinal cord injury level above T10;
• Diagnosed with spinal cord injury for ≥ 8 months and ≤ 36 months;
• WISCI II score < 13;
• No significant improvement in motor dysfunction after rehabitation over the past 2 months.
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Epidural Electrical Stimulation (EES) + Standard Rehabilitation

Experimental group

Description:

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

Treatment:

Procedure: Somatosensory Evoked Potentials (SEPs)

Procedure: Motor Evoked Potentials (MEPs)

Procedure: Standard Rehabilitation Therapy

Procedure: Epidural Electrical Stimulation

Radiation: Diffusion Tensor Imaging (DTI)

Radiation: positron emission tomography-computed tomography (PET-CT)