Multilevel multimodal neurophysiology of epidural spinal cord stimulation in SCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will record brain activity (EEG), spinal activity (SEG), and muscle activity (EMG) together with clinical assessments to understand how epidural spinal cord stimulation changes neural communication and function in SCI patients and non-SCI controls. The study compares two cohorts to see how baseline neural signals relate to changes after stimulation. It uses noninvasive and implant-based approaches to map neural pathways and functional recovery potential.

Why it matters

Who can join: the full rules

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.

Where it's running

• Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
  Hualien City, Taiwan Recruiting

Study contacts

• Principal investigator: Yu-Chen Chen, M.D., Ph.D — Hualien Tzu Chi General Hospital
• Study coordinator: Yu-Chen Chen, M.D., Ph.D
• Email: spring810569@gmail.com
• Phone: +886-3-856-1825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.