Набор скоро начнётся NCT07488780

Language Network Prehab Via fMRI Neurofeedback

Без фазы С лечением Glioma Glioma Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: fMRI.
Кому может быть актуально: Состояния в реестре: Glioma, Glioma Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

fMRI Neurofeedback for Prehabilitation of the Language Network in Patients Undergoing Radical Glioma Surgery

Обзор

This is an interventional neuroimaging study that will examine whether fMRI neurofeedback can shift language network activity away from regions affected by glioma prior to surgery.

Подробное описание

The primary objective of this study is to establish the feasibility and acceptability of implementing a brief, device-based fMRI neurofeedback (NF) intervention during the standard presurgical window in patients with WHO grade II-III gliomas involving eloquent language cortex.

The secondary objectives of this study are to obtain preliminary mechanistic and behavioral data regarding the effects of fMRI NF-based prehabilitation on language network organization and language performance. These secondary objectives are exploratory and intended to inform the design of a future randomized clinical trial.

The intervention will be conducted during the standard preoperative window and will not alter or delay clinical care. All participants will receive the same neurofeedback intervention as the primary goal of this study is to establish feasibility and generate pilot data. The study involves repeated within-subject assessments, including baseline and post-intervention neuropsychological testing and task-based fMRI measures, allowing each participant to serve as their own reference point for exploratory analyses.

Вмешательства

Устройство fMRI
Real-time functional magnetic resonance imaging (fMRI) neurofeedback (NF)

Первичные конечные точки

Number of participants enrolled to assess feasibility [Срок оценки: up to 6 months]
Number of participants completing all study visits to assess feasibility [Срок оценки: From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days]
Number of device-related adverse events to assess safety [Срок оценки: From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days]
Mean score Patient Experience Questionnaire (PEQ) to assess acceptability [Срок оценки: Post surgery at 10 days]

Критерии участия

Критерии включения

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Diagnosis of WHO grade II-III glioma involving eloquent language cortex
Scheduled for surgical resection
MRI-compatible
Ability to perform the simple language tasks required for fMRI and neurofeedback
Residence within 2 hours of Yale MRRC and ability and willingness to make multiple visits for study participation