NCT07306052 Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury
| NCT ID | NCT07306052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Spinal Cord Injuries (SCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-12-12 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2025-12-12 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 B-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 2, 4, 7, 10, and 13 months post-implantation to evaluate the longitudinal effects. The primary assessments include the Walking Index for Spinal Cord Injury II (WISCI II), the Spinal Cord Independence Measure (SCIM III), and the adverse event. Secondary outcome measures encompass the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), the Functional Independence Measure (FIM), the Modified Ashworth Scale (MAS), the Penn Spasm Frequency Scale, the 10-Meter Walk Test (10mWT), the 6-Minute Walk Test (6minWT), 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.
Eligibility Criteria
Inclusion Criteria: * Age between 16 and 70 years. * Diagnosed with traumatic spinal cord injury for ≥ 6 months and ≤ 60 months. * American Spinal Injury Association Impairment Scale (AIS) grade B-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. Exclusion Criteria: * 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.
Contact & Investigator
Junming Zhu
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT07306052 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 70 Years, studying Spinal Cord Injuries (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07306052 currently recruiting?
Yes, NCT07306052 is actively recruiting participants. Contact the research team at dr.zhujunming@zju.edu.cn for enrollment information.
Where is the NCT07306052 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07306052 clinical trial?
NCT07306052 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Junming Zhu at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 12 participants.