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Recruiting NCT06458153

Imaging Speech in Neurotypical Adults and Individuals With Cerebellar Stroke

No phase Interventional Stroke Cerebellum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neural responses to speech functional localizer, Neural responses to silent articulation, Neural responses to self vs. externally generated speech, Event-related potentials for speech.
Who it may be relevant to
Registry conditions: Stroke, Cerebellum. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

High-resolution Functional Imaging of Speech-induced Sensory Modulation

Overview

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).

Detailed description

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT06458153 · STUDY23070083 · 1R01DC020963-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗