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Activo, sin reclutamientoNCT06645613Registro de ClinicalTrials.gov

TMS With Real-time E-field and EEG Source Imaging

Healthy Volunteers Only

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - 65 años
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
50 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The goal of this study is to develop and validate an approach for accurate targeting and stimulation of brain networks using transcranial magnetic stimulation (TMS) using information from magnetic resonance imaging (MRI) data. This study requires two visits from each participant.

In the first visit, the participant will be scanned by MRI scanners to collect data from the brain.

Next, the data will be analyzed by the researcher to model the connections between different regions of the brain to determine the stimulation areas related to the so-called frontoparietal network.

In the second visit, the participants will take four TMS sessions with different types of stimulations applied to the computed targets and complete a computer-based task named multi-source interference task. Electroencephalogram (EEG) data will be collected during the TMS stimulations and tasks.

The main hypothesis is that applying TMS stimulations to the brain targets reduces the response time and response error in the tasks.

Leer la descripción completa

The main goal of this study is to develop and validate an approach to target and stimulate brain networks using transcranial magnetic stimulation using information from magnetic resonance imaging (MRI).

Participants in this study will first be scanned using an MRI scanner to collect data from the brain. The MRI session will take about 40 minutes to acquire anatomical MRI, diffusion MRI, and resting-state functional MRI from the subjects.

Next, the researchers will analyze the MRI data to determine the stimulation areas of each participant. The method will provide two target areas in the brain, including an area in the left dorsolateral prefrontal cortex (DLPFC) and an area in the left inferior parietal lobule (IPL), which are involved in the frontoparietal network related to the executive control functions of the brain.

In the second visit, the participants will take TMS stimulations to the determined brain targets at DLPFC and IPL. The standard intermittent theta-burst (iTBS) protocol will be applied to the targets. To evaluate the effect of TMS stimulations, the participants will perform a computer-based task, named multi-source interference task (MSIT), before the TMS stimulation and another task after the TMS stimulations. The participants will click mouse buttons to respond to instructions in the tasks.

The response time and response error of the tasks will be the outcome measures of this study. The hypothesis is that applying TMS stimulations to the developed brain network targets reduces the response time and response error.

During the TMS stimulations and tasks, electroencephalogram (EEG) data will be collected from the participants. The EEG data, MRI data, and TMS-induced electric field maps will be analyzed and visualized using a software named SlicerTMS. However, the information shown in SlicerTMS will not be used to change the stimulation protocol in this study.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

1. Age greater than 18 and less than 65 years.
2. Able to understand and give informed consent/assent.
3. No prior neuropsychiatric, neurological disorders, epilepsy, or seizures.
4. No metal implants.
5. Absent of lesions or tumors from MRI scans.

Exclusion Criteria:

1. The presence of a cardiac pacemaker or pacemaker wires.
2. Metallic particles in the eye.
3. Vascular clips in the head or previous neurosurgery.
4. Prosthetic heart valves.
5. Significant claustrophobia.
6. Non-fixed metallic particles (shrapnel).
7. Any magnetic metallic particles in the body.
8. Failure to assure non-pregnant status.
9. Failure to perform the task of lying still.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Enmascaramiento simple
Sham Transcranial Magnetic Stimulation

Sham TMS coils will be applied to stimulate the brain targets. No magnetic field will be generated using the sham coil. It will play sounds similar to the true TMS stimulations with the pulsed weak electric current applied to the scalp to generate a similar feeling as in true stimulations.

Device: Transcranial Magnetic Stimulation Device

Transcranial Magnetic Stimulation

TMS with the intermittent theta burst stimulation protocol will be applied to the computed brain targets based on the MRI data of each participants.

Device: Transcranial Magnetic Stimulation Device

Transcranial Magnetic Stimulation Device DEVICE

Transcranial magnetic stimulation uses FDA-approved coils to generate varying magnetic fields in the brain of the participant and induce an electric field in the underlying brain tissue. The standard intermittent Theta Burst Stimulation (iTBS) TMS protocol will be applied in this study. The same coil can be applied to generate sham stimulations that only generate sound and stimulations to the scalp without stimulating the brain.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

choice reaction time (CRT)

Plazo: 5 to 15 minutes right before and after each TMS session

CRT is the time that the participant takes to click the mouse button in the computer-based Multi-Source Interference Task.

Medidas secundarias

response error

Plazo: 5 to 15 minutes right before and after each TMS session

The rate of incorrect response in the MSIT task.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

MGH at the Navy YardCharlestown, Massachusetts, United StatesEstado desconocido

Equipo y fechas

Patrocinador principal
Brigham and Women's Hospital
Inicio del estudio
1 mar 2026 Real
Finalización primaria
1 sept 2029 Estimado
Finalización del estudio
1 sept 2029 Estimado
Primera publicación
17 oct 2024 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Precision TMS With Integrated Visualization and Analysis of Real-time E-field and EEG Source Imaging

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026