Multilevel Multimodal Neurophysiological Integration for Investigating the Network Modulatory Mechanisms of Epidural Spinal Cord Stimulation
23 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
30
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Sheng-Tzung Tsai, M.D., Ph.D.
- Número de teléfono: 13054 +886-3-856-1825
- Correo electrónico: flydream.tsai@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Yu-Chen Chen, M.D., Ph.D
- Número de teléfono: 13054 +886-3-856-1825
- Correo electrónico: spring810569@gmail.com
Ubicaciones de estudio
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Hualien City, Taiwán
- Reclutamiento
- Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
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Contacto:
- Sheng-Tzung Tsai, M.D., Ph.D
- Número de teléfono: 13054 +886-3-856-1825
- Correo electrónico: flydream.tsai@gmail.com
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Contacto:
- Yu-Chen Chen, M.D., Ph.D
- Número de teléfono: 13054 +886-3-856-182
- Correo electrónico: spring810569@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Neurosurgery patient at Buddhist Tzu Chi General Hospital, Hualien
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Peak-to-peak amplitude of spinal evoked responses
Periodo de tiempo: baseline; at 7、20 days after the implantation
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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.
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baseline; at 7、20 days after the implantation
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Latency of spinal evoked responses
Periodo de tiempo: baseline; at 7、20 days after the implantation
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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.
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baseline; at 7、20 days after the implantation
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Area under the curve (AUC) of spinal evoked responses
Periodo de tiempo: Baseline; at 7、20 days after the implantation
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The area under the evoked response waveform will be calculated in µV、RMT(%)) to quantify the overall neural response elicited by stimulation.
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Baseline; at 7、20 days after the implantation
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Recruitment curve of spinal evoked responses
Periodo de tiempo: baseline; at 7、20 days after the implantation
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Recruitment curves will be constructed by plotting peak-to-peak amplitude (µV) to characterize spinal neural excitability and recruitment properties.
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baseline; at 7、20 days after the implantation
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EEG spectral power
Periodo de tiempo: baseline; 7、20 days after the implantation
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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.
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baseline; 7、20 days after the implantation
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SEG spectral power
Periodo de tiempo: baseline; 7、20 days after the implantation
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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.
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baseline; 7、20 days after the implantation
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yu-Chen Chen, M.D., Ph.D, Hualien Tzu Chi General Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
31 de diciembre de 2030
Finalización del estudio (Estimado)
31 de diciembre de 2030
Fechas de registro del estudio
Enviado por primera vez
20 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de julio de 2026
Publicado por primera vez (Actual)
29 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB115-040-A
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
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