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

NCT07732972 | Recruiting FDA Device

• 1 other identifier: IRB115-040-A
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury(SCI)

Outcome Measures

Primary Outcomes (6)

• 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.

  baseline; at 7、20 days after the implantation

• 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.

  baseline; at 7、20 days after the implantation

• 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.

  Baseline; at 7、20 days after the implantation

• 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.

  baseline; at 7、20 days after the implantation

• EEG spectral power

  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.

  baseline; 7、20 days after the implantation

• SEG spectral power

  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.

  baseline; 7、20 days after the implantation

Study Arms (2)

Group without spinal cord injury

Adults aged 20-70 years without spinal cord injury who have chronic neuropathic pain and have undergone temporary epidural spinal cord stimulation (EES). Neural activity will be evaluated using simultaneous spinal electrogram (SEG), electroencephalography (EEG), and electromyography (EMG) recordings during EES.

Spinal cord injury group

This cohort includes adults aged 20-70 years with chronic spinal cord injury who have undergone temporary epidural spinal cord stimulation (EES). Participants with AIS grades A-D and injury levels from C3 to L1 will be included. Neural activity will be evaluated using spinal electrogram (SEG), electroencephalography (EEG), and electromyography (EMG) recordings during EES.

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

Interventions

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.

Spinal cord injury group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurosurgery patient at Buddhist Tzu Chi General Hospital, Hualien

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Yu-Chen Chen, M.D., Ph.D

  Hualien Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Chen Chen, M.D., Ph.D

CONTACT

+886-3-856-1825; spring810569@gmail.com

Sheng-Tzung Tsai, M.D., Ph.D.

CONTACT

+886-3-856-1825; flydream.tsai@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-06

Locations

TW (1)