- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07827456
MRI-Guided Temporal Interference Stimulation for Parkinson's Disease
Efficacy of MRI-Guided Transcranial Temporal Interference Electrical Stimulation (tTIS) Modulation for Parkinson's Disease: An Exploratory Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18-75 years (inclusive), any gender.
- Diagnosis of idiopathic Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 edition).
- Hoehn and Yahr stage 2-4 (inclusive) during the "off" state.
- Documented response to levodopa (>33% improvement), with a stable anti-parkinsonian medication regimen for at least 4 weeks prior to screening, and no dose adjustments during the study.
- Voluntary signed informed consent, and ability to understand and comply with the study protocol to complete the study.
- No significant cognitive impairment (Montreal Cognitive Assessment [MoCA] score ≥21).
Exclusion Criteria:
Inability or unwillingness to comply with the study protocol and/or inability to provide written informed consent;
Presence of a significant medical condition that may interfere with study procedures or confound the assessment of study endpoints;
Presence of a severe psychiatric disorder that may affect the participant's ability to comply with the study protocol;
A history of psychiatric disorders or current severe depression or anxiety;
Presence of metallic implants in the brain;
Known pregnancy or current breastfeeding;
Severe neurological disorders, such as a brain tumor;
Severe cardiac disease, including the presence of an implanted cardiac pacemaker;
Scalp lesions, inflammation, infection, active bleeding, or an increased bleeding tendency;
Any other current medical condition for which the use of transcranial electrical stimulation may pose an unacceptable risk;
A history of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease;
Inability to undergo magnetic resonance imaging (MRI), such as because of claustrophobia or implanted metallic devices;
Inability to cooperate with or complete the required assessments; or any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Experimental group A
Patients in this group receive individualized targeting based on MRI head modeling.
During the medication-off period, they first undergo 130 Hz combined GPi and STN stimulation (GPi+STN), and one week later, they undergo 130 Hz GPi stimulation alone.
|
All participants will receive individualized T1-weighted MRI scans for computational modeling to determine optimized electrode placement and stimulation parameters for transcranial temporal interference stimulation targeting the subthalamic nucleus.
The stimulation protocol is designed to generate a focal 130 Hz interference field in the target region while minimizing cortical activation.
Parameters including electrode positions and current intensity are customized based on each participant's unique neuroanatomy to ensure precise and tailored neuromodulation.
|
|
Comparador activo: Experimental group B
Patients in this group receive individualized targeting based on MRI head modeling.
During the medication-off period, they first undergo 130 Hz GPi stimulation alone, and one week later, they undergo 130 Hz combined GPi and STN stimulation (GPi+STN).
|
All participants will receive individualized T1-weighted MRI scans for computational modeling to determine optimized electrode placement and stimulation parameters for transcranial temporal interference stimulation targeting the subthalamic nucleus.
The stimulation protocol is designed to generate a focal 130 Hz interference field in the target region while minimizing cortical activation.
Parameters including electrode positions and current intensity are customized based on each participant's unique neuroanatomy to ensure precise and tailored neuromodulation.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Periodo de tiempo: at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation
|
The motor function of patients was assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), which has a total score range of 0 to 132.
In this scale, a higher score indicates greater severity of motor symptoms and therefore a worse outcome, with 0 representing no impairment and 132 representing the most severe impairment.
Changes in the score reflect the degree of improvement in motor function.
|
at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The incidence of SAE
Periodo de tiempo: From the first stimulation session until the end of the study follow-up period (each stimulation session lasts for 30 minutes; total study duration including follow-up is 3 weeks). SAEs will be monitored and recorded continuously throughout this period.
|
The incidence of SAE
|
From the first stimulation session until the end of the study follow-up period (each stimulation session lasts for 30 minutes; total study duration including follow-up is 3 weeks). SAEs will be monitored and recorded continuously throughout this period.
|
|
All-cause mortality
Periodo de tiempo: 1month after randomization
|
All-cause mortality
|
1month after randomization
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20260599
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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