Spinal Cord Injury(SCI)
Conditions
Brief summary
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
DEVICEparticipants 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.
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak-to-peak amplitude of spinal evoked responses | baseline; at 7、20 days after the implantation | Peak-to-peak amplitude of spinal evoked responses will be measured in microvolts (µV) to quantify the magnitude of neural activation under different stimulation conditions. |
| Latency of spinal evoked responses | baseline; at 7、20 days after the implantation | Response latency of spinal evoked responses will be measured in milliseconds (ms) from stimulus onset to the onset or peak of the response to evaluate neural conduction characteristics. |
| Area under the curve (AUC) of spinal evoked responses | Baseline; at 7、20 days after the implantation | The area under the evoked response waveform will be calculated in µV、RMT(%)) to quantify the overall neural response elicited by stimulation. |
| Recruitment curve of spinal evoked responses | baseline; at 7、20 days after the implantation | Recruitment curves will be constructed by plotting peak-to-peak amplitude (µV) to characterize spinal neural excitability and recruitment properties. |
| EEG spectral power | baseline; 7、20 days after the implantation | EEG spectral power will be calculated using Morlet wavelet transform and expressed in decibels (dB) for the theta (θ), alpha (α), beta (β), and gamma (γ) frequency bands to quantify changes in neural oscillatory activity. |
| SEG spectral power | baseline; 7、20 days after the implantation | SEG spectral power will be calculated using Morlet wavelet transform and expressed in decibels (dB) for the theta (θ), alpha (α), beta (β), and gamma (γ) frequency bands to quantify changes in spinal neural oscillatory activity. |
Countries
Taiwan
Contacts
CONTACTYu-Chen Chen, M.D., Ph.D
CONTACTSheng-Tzung Tsai, M.D., Ph.D.
PRINCIPAL_INVESTIGATORYu-Chen Chen, M.D., Ph.D
Hualien Tzu Chi General Hospital
Outcome results
None listed