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

23 juli 2026 bijgewerkt door: Buddhist Tzu Chi General Hospital
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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

30

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Taiwan
      • Hualien City, Taiwan
        • Werving
        • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Neurosurgery patient at Buddhist Tzu Chi General Hospital, Hualien

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Peak-to-peak amplitude of spinal evoked responses
Tijdsspanne: 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.
baseline; at 7、20 days after the implantation
Latency of spinal evoked responses
Tijdsspanne: 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.
baseline; at 7、20 days after the implantation
Area under the curve (AUC) of spinal evoked responses
Tijdsspanne: 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.
Baseline; at 7、20 days after the implantation
Recruitment curve of spinal evoked responses
Tijdsspanne: 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.
baseline; at 7、20 days after the implantation
EEG spectral power
Tijdsspanne: 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.
baseline; 7、20 days after the implantation
SEG spectral power
Tijdsspanne: 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.
baseline; 7、20 days after the implantation

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Buddhist Tzu Chi General Hospital

Onderzoekers

  • Hoofdonderzoeker: Yu-Chen Chen, M.D., Ph.D, Hualien Tzu Chi General Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

31 december 2030

Studie voltooiing (Geschat)

31 december 2030

Studieregistratiedata

Eerst ingediend

20 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juli 2026

Eerst geplaatst (Werkelijk)

29 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juli 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB115-040-A

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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