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Идёт набор NCT06458153

Imaging Speech in Neurotypical Adults and Individuals With Cerebellar Stroke

Без фазы С лечением Stroke Cerebellum

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: Neural responses to speech functional localizer, Neural responses to silent articulation, Neural responses to self vs. externally generated speech, Event-related potentials for speech.
Кому может быть актуально
Состояния в реестре: Stroke, Cerebellum. 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 →
Официальное название

High-resolution Functional Imaging of Speech-induced Sensory Modulation

Обзор

The goal of this research study is to learn how the brain areas that plan and control movement interact with the areas responsible for hearing and perceiving speech in healthy adults and people who have had cerebellar strokes. The main questions it aims to answer are: 1. What regions of the brain's sensory systems show changes in their activity related to speech? 2. To what extent do these regions help listeners detect and correct speech errors? 3. What is the role of the cerebellum (a part of the brain in the back of the head) in these activities? Participants will be asked to complete several experimental sessions involving behavioral speech and related tests and non-invasive brain imaging using electroencephalography (EEG) and functional magnetic resonance imaging (fMRI).

Подробное описание

This study aims to provide an integrated view of brain systems underlying predictive coding in speech with unprecedented detail using ultra-high field (7 Tesla) functional magnetic resonance imaging. The overall approach is a condition-intensive within-subjects design, with extensive sampling of individual participants, including a group who have had strokes impacting the cerebellum, across multiple sessions.

Participants will be asked to complete up to 6 sessions. Passing a hearing assessment using standard audiological procedures, conducted at the start of the first session, is a requirement for participation. The experimental sessions involve behavior and non-invasive brain imaging.

Investigators will ask participants to perform several short tasks to measure different aspects of their speech production and speech perception (e.g., reading passages or words aloud, making judgements about sounds).

In one session, Investigators will measure electroencephalography (EEG) while participants complete tasks involving producing and hearing speech sounds. Participants will be fitted with an elastic cap and up to 32 non-invasive recording electrodes.

In other sessions, investigators will measure structural and functional magnetic resonance imaging (fMRI). Structural images demonstrate the unique brain anatomy of the participant. Functional images will be obtained while the participant completes specific tasks involving listening, speaking, or completing other motor actions (e.g., pressing a button). All participants will be screened for MRI risk factors prior to each session.

Вмешательства

  • Поведенческое Neural responses to speech functional localizer
    Measuring speech-related brain activity using fMRI during a speech listening task.
  • Поведенческое Neural responses to silent articulation
    Measuring speech-related brain activity using fMRI during a silent articulation task.
  • Поведенческое Neural responses to self vs. externally generated speech
    Measuring speech-related brain activity using fMRI during self-generated vs. externally-generated speech.
  • Поведенческое Event-related potentials for speech
    Measuring electroencephalography (EEG) based evoked potentials for self vs. externally generated speech
  • Поведенческое Neural responses to induced speech errors
    Measuring speech-related brain activity using fMRI during conditions that induce auditory speech errors.
  • Поведенческое Neural responses to sensory-motor adaptation
    Measuring brain activity using fMRI during a learning task with sustained altered auditory feedback.
  • Поведенческое Speech production behaviors
    Behavioral measurements of speech during reading passages and words
  • Поведенческое Auditory acuity testing
    Measurements of auditory acuity during listening tasks.
  • Поведенческое Neural responses to learning a non-speech auditory motor behavior
    Mapping of brain areas using fMRI during learning of non-speech sound-evoking movements.

Первичные конечные точки

  • Blood oxygenation level dependent (BOLD) responses to self vs. externally generated speech [Срок оценки: One session lasting 2-3 hours, within 12 months of enrollment]
  • BOLD responses related to pre-speech auditory modulation [Срок оценки: One session lasting 2-3 hours, within 12 months of enrollment]
  • EEG responses to self vs. externally generated speech [Срок оценки: One session lasting 2-3 hours, within 12 months of enrollment]
  • BOLD responses to induced auditory errors [Срок оценки: One session lasting 2-3 hours, within 12 months of enrollment]
  • BOLD responses during adaptation to auditory perturbations [Срок оценки: One session lasting 2-3 hours, within 12 months of enrollment]
  • BOLD responses during learning of non-speech auditory motor targets [Срок оценки: One session lasting 2-3 hours, within 12 months of enrollment]
Вторичные конечные точки (5)
  • BOLD responses to speech listening task [Срок оценки: One session lasting 2-3 hours, within 12 months of enrollment]
  • BOLD responses to silent articulation task [Срок оценки: One session lasting 2-3 hours, within 12 months of enrollment]
  • Speech formant frequencies [Срок оценки: First session lasting 2-3 hours, within 12 months of enrollment]
  • Spontaneous Speech Synchronization Index [Срок оценки: First session lasting 2-3 hours, within 12 months of enrollment]
  • Auditory acuity [Срок оценки: First session lasting 2-3 hours, within 12 months of enrollment]

Критерии участия

Критерии включения

Cohort 1 (neurotypical adults):

  • Age 18-49
  • Right-handed
  • Native English speaker

Cohort 2 (people with cerebellar lesions):

  • Age 18 or older
  • Right-handed
  • Native English speaker
  • History of cerebellar stroke

Cohort 3 (controls matched to Cohort 2)

  • Age 18 or older
  • Right-handed
  • Native English speaker

Критерии исключения

Cohort 1 (neurotypical adults):

  • Presence of MRI risk factors: metal and/or electromagnetic devices (e.g., pacemakers, neurostimulators) in the body, previous shrapnel injuries, use of an intrauterine device containing metal, claustrophobia, pregnant or possibly pregnant
  • History of neurological / neurodegenerative disease or severe brain injury (e.g., stroke or severe traumatic brain injury)
  • Hearing loss, defined by pure tone thresholds >25 decibels (dB) hearing level (HL) at octave frequencies between 250-8000 Hz
  • Clinical diagnosis and/or treatment for schizophrenia or other psychotic disorders
  • Clinical diagnosis and/or treatment for neurocognitive disorders (e.g., dementia, delirium)
  • Presence of a severe and unmanaged, clinically diagnosed attention disorder
  • Clinically diagnosed with or treated for a speech, language, or hearing disorder
  • Head circumference greater than 60cm or weight greater than 300 pounds
  • History of severe claustrophobia
  • Currently pregnant

Cohort 2 (people with cerebellar lesions):

  • Presence of MRI risk factors: metal and/or electromagnetic devices (e.g., pacemakers, neurostimulators) in the body, previous shrapnel injuries, use of an intrauterine device containing metal, claustrophobia, pregnant or possibly pregnant
  • History of neurological / neurodegenerative disease or severe brain injury other than stroke
  • Hearing loss, defined by pure tone thresholds >50 dB HL at octave frequencies between 250-4000 Hz
  • Clinical diagnosis and/or treatment for schizophrenia or other psychotic disorders
  • Clinical diagnosis and/or treatment for neurocognitive disorders (e.g., dementia, delirium)
  • Presence of a severe and unmanaged, clinically diagnosed attention disorder
  • Head circumference greater than 60cm or weight greater than 300 pounds
  • History of severe claustrophobia
  • Currently pregnant

Cohort 3 (controls matched to Cohort 2):

  • Presence of MRI risk factors: metal and/or electromagnetic devices (e.g., pacemakers, neurostimulators) in the body, previous shrapnel injuries, use of an intrauterine device containing metal, claustrophobia, pregnant or possibly pregnant
  • History of neurological / neurodegenerative disease or severe brain injury (e.g., stroke or severe traumatic brain injury)
  • Hearing loss, defined by pure tone thresholds >50 dB HL at octave frequencies between 250-4000 Hz
  • Clinical diagnosis and/or treatment for schizophrenia or other psychotic disorders
  • Clinical diagnosis and/or treatment for neurocognitive disorders (e.g., dementia, delirium)
  • Presence of a severe and unmanaged, clinically diagnosed attention disorder
  • Clinically diagnosed with or treated for a speech, language, or hearing disorder
  • Head circumference greater than 60cm or weight greater than 300 pounds
  • History of severe claustrophobia
  • Currently pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06458153 · STUDY23070083 · 1R01DC020963-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗