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

Zhejiang University

Status: Enrolling

Conditions: Spinal Cord Injuries (SCI)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07207798

2025-0252

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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:

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

Procedure: Motor Evoked Potentials (MEPs)

Procedure: Standard Rehabilitation Therapy

Procedure: Somatosensory Evoked Potentials (SEPs)

Procedure: Epidural Electrical Stimulation

Radiation: Diffusion Tensor Imaging (DTI)