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MRI-Guided Temporal Interference Stimulation for Parkinson's Disease

14 de septiembre de 2026 actualizado por: Tang Zhouping, Tongji Hospital

Efficacy of MRI-Guided Transcranial Temporal Interference Electrical Stimulation (tTIS) Modulation for Parkinson's Disease: An Exploratory Study

This study aims to evaluate the efficacy and safety of tTIS treatment in patients with Parkinson's disease (PD). The study will enroll eligible PD patients and randomly assign them to two groups: Group A will first receive combined GPi and STN stimulation, followed by GPi stimulation one week later; Group B will first receive GPi stimulation, followed by combined GPi and STN stimulation one week later. The MDS-UPDRS Part III will be assessed at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation for each session, in order to evaluate and compare the therapeutic effects of tTIS targeting GPi alone versus combined GPi and STN stimulation on motor symptoms in PD patients, and to assess the differential efficacy of tTIS at different targets among PD patients with varying symptoms.

Descripción general del estudio

Estado

Aún no reclutando

Tipo de estudio

Intervencionista

Inscripción (Estimado)

26

Fase

  • No aplica

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

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

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

  • 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

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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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)

15 de septiembre de 2026

Finalización primaria (Estimado)

10 de junio de 2027

Finalización del estudio (Estimado)

10 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Publicado por primera vez (Actual)

18 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

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.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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