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Recruiting NCT07732972

Multilevel Multimodal Neurophysiological Integration for Investigating the Network Modulatory Mechanisms of Epidural Spinal Cord Stimulation

— Observational Spinal Cord Injury(SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: participants will be divided into two disease cohorts: the spinal cord injury (SCI) group and the non-spinal cord injury (non-SCI) group..
Who it may be relevant to
Registry conditions: Spinal Cord Injury(SCI). Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study will examine how the brain, spinal cord, and muscles communicate in people with spinal cord injury. Researchers will use noninvasive brain and muscle recordings together with spinal electrical recordings to better understand how epidural spinal cord stimulation (EES) affects nerve function. The results may help develop more effective and personalized rehabilitation treatments for people with spinal cord injury.

Detailed description

This study aims to investigate the neural activity of individuals with SCI by simultaneously recording spinal electrograms (SEG), electroencephalography (EEG), and electromyography (EMG). Multimodal neurophysiological recordings will be used to evaluate communication between the brain, spinal cord, and muscles before and after EES. Clinical assessments of neurological function, upper extremity motor performance, and functional independence will also be performed to examine the relationship between electrophysiological changes and functional recovery.

Interventions

  • Device participants will be divided into two disease cohorts: the spinal cord injury (SCI) group and the non-spinal cord injury (non-SCI) group.
    This observational case-control study includes two groups: a spinal cord injury (SCI) group and a non-SCI group. The SCI group consists of patients diagnosed with SCI by physicians. Both groups have undergone temporary epidural spinal cord stimulation (EES), and spinal electrophysiological signals will be recorded during stimulation in the SCI group to evaluate neural activity.

Primary outcome measures

  • Peak-to-peak amplitude of spinal evoked responses [Time frame: baseline; at 7、20 days after the implantation]
  • Latency of spinal evoked responses [Time frame: baseline; at 7、20 days after the implantation]
  • Area under the curve (AUC) of spinal evoked responses [Time frame: Baseline; at 7、20 days after the implantation]
  • Recruitment curve of spinal evoked responses [Time frame: baseline; at 7、20 days after the implantation]
  • EEG spectral power [Time frame: baseline; 7、20 days after the implantation]
  • SEG spectral power [Time frame: baseline; 7、20 days after the implantation]

Eligibility criteria

Inclusion criteria

A. Non-Spinal Cord Injury (Non-SCI) Group

  • Individuals without spinal cord injury.
  • Patients diagnosed with chronic neuropathic pain who meet the criteria for routine temporary epidural spinal cord stimulation (EES) implantation therapy.
  • Patients who have undergone temporary epidural spinal cord stimulation (EES) implantation.
  • Ability to understand and follow motor instructions.
  • Age between 20 and 70 years. B. Spinal Cord Injury (SCI) Group
  • Patients with chronic spinal cord injury.
  • Patients who have undergone temporary epidural spinal cord stimulation (EES) implantation.
  • American Spinal Injury Association Impairment Scale (AIS) grades A-D.
  • Spinal cord injury levels between C3 and L1.
  • Ability to understand and follow motor instructions.
  • Age between 20 and 70 years.

Exclusion criteria

  • Individuals with severe psychiatric disorders or cognitive impairments, including major depressive disorder, schizophrenia, or dementia, that may affect their ability to understand the study procedures or comply with study instructions.
  • Individuals who are unable to maintain consciousness, follow instructions, or complete study tasks, including motor tasks, isometric contractions, or resting-state tasks.
  • Individuals with severe medical conditions and unstable clinical status, such as uncontrolled cardiovascular disease, severe infection, respiratory failure, or other conditions deemed unsuitable for study participation by the attending physician.
  • Individuals with abnormal positioning, inadequate fixation, or complications related to temporary epidural spinal cord stimulation (EES) leads, including infection, significant pain, or neurological deterioration, as determined by clinical evaluation to be unsuitable for study recordings.
  • Individuals currently using medications that may significantly affect neurophysiological signals, such as high-dose sedatives, anesthetic agents, or other medications considered by the research team to interfere with data interpretation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Taiwan · 1 center
  • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City

Identifiers

NCT: NCT07732972 · IRB115-040-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗