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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
SponsorBuddhist Tzu Chi General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Neurosurgery patient at Buddhist Tzu Chi General Hospital, Hualien

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • participants will be divided into two disease cohorts: the spinal cord injury (SCI) group and the non-spinal cord injury (non-SCI) group.

    Device

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Group without spinal cord injury0 interventions
Group B: Spinal cord injury group1 intervention

Trial outcomes

Primary outcomes

1

Peak-to-peak amplitude of spinal evoked responses

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.

Time frame
baseline; at 7、20 days after the implantation
2

Latency of spinal evoked responses

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.

Time frame
baseline; at 7、20 days after the implantation
3

Area under the curve (AUC) of spinal evoked responses

The area under the evoked response waveform will be calculated in µV、RMT(%)) to quantify the overall neural response elicited by stimulation.

Time frame
Baseline; at 7、20 days after the implantation
4

Recruitment curve of spinal evoked responses

Recruitment curves will be constructed by plotting peak-to-peak amplitude (µV) to characterize spinal neural excitability and recruitment properties.

Time frame
baseline; at 7、20 days after the implantation

Secondary outcomes

Other outcomes

Sponsors and contacts

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