Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury
NCT ID: NCT07306052
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2025-12-12
2027-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epidural spinal cord stimulation + Standard Rehabilitation
Participants receive the epidural spnial cord stimulation combined with individualized standard rehabilitation therapy for 12 months.
Epidural spinal cord stimulation
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.
Rehabilitation Therapy
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.
positron emission tomography-computed tomography (PET-CT)
PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography.
Somatosensory Evoked Potentials (SEPs)
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.
Motor Evoked Potentials (MEPs)
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.
Diffusion Tensor Imaging (DTI)
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.
Interventions
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Epidural spinal cord stimulation
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.
Rehabilitation Therapy
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.
positron emission tomography-computed tomography (PET-CT)
PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography.
Somatosensory Evoked Potentials (SEPs)
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.
Motor Evoked Potentials (MEPs)
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.
Diffusion Tensor Imaging (DTI)
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
16 Years
65 Years
ALL
No
Sponsors
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Zhejiang University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Junming Zhu
Chief Physician
Principal Investigators
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Junming Zhu
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Junming Zhu, Chief Physician
Role: primary
Zhoule Zhu, Attending Physician
Role: backup
Other Identifiers
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2025-1940
Identifier Type: -
Identifier Source: org_study_id