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
10 participants
INTERVENTIONAL
2025-03-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epidural Electrical Stimulation (EES) + Standard Rehabilitation
Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.
Epidural Electrical Stimulation
Epidural Electrical Stimulation (EES) 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.
Standard 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.
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.
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.
Interventions
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Epidural Electrical Stimulation
Epidural Electrical Stimulation (EES) 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.
Standard 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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
16 Years
60 Years
ALL
No
Sponsors
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College of Biomedical Engineering and Instrumentation Science, Zhejiang University
UNKNOWN
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, Chief Physician
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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Other Identifiers
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2025-1040
Identifier Type: -
Identifier Source: org_study_id
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