Clinical trial NCT06458153: Imaging Speech in Neurotypical Adults and Individuals With Cerebellar Stroke
Official title: High-resolution Functional Imaging of Speech-induced Sensory Modulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Cerebellum
Keywords: fmri
speech production
cerebellum
auditory-motor integration
speech motor control
neuroimaging
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The single group model involves assessing the neural basis of multiple behavioral tasks in three cohorts. Cohort 1 is neurotypical adults. Cohort 2 is people with post-stroke cerebellar lesions. Cohort 3 is a group of control participants that will be matched to Cohort 2. The behavioral interventions are overlapping between cohorts, though Cohort 1 will complete additional sessions.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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

Primary outcomes:
measure: Blood oxygenation level dependent (BOLD) responses to self vs. externally generated speech
timeFrame: One session lasting 2-3 hours, within 12 months of enrollment
measure: BOLD responses related to pre-speech auditory modulation
timeFrame: One session lasting 2-3 hours, within 12 months of enrollment
measure: EEG responses to self vs. externally generated speech
timeFrame: One session lasting 2-3 hours, within 12 months of enrollment
measure: BOLD responses to induced auditory errors
timeFrame: One session lasting 2-3 hours, within 12 months of enrollment
measure: BOLD responses during adaptation to auditory perturbations
timeFrame: One session lasting 2-3 hours, within 12 months of enrollment
measure: BOLD responses during learning of non-speech auditory motor targets
timeFrame: One session lasting 2-3 hours, within 12 months of enrollment
Secondary outcomes:
measure: BOLD responses to speech listening task
timeFrame: One session lasting 2-3 hours, within 12 months of enrollment
measure: BOLD responses to silent articulation task
timeFrame: One session lasting 2-3 hours, within 12 months of enrollment
measure: Speech formant frequencies
timeFrame: First session lasting 2-3 hours, within 12 months of enrollment
measure: Spontaneous Speech Synchronization Index
timeFrame: First session lasting 2-3 hours, within 12 months of enrollment
measure: Auditory acuity
timeFrame: First session lasting 2-3 hours, within 12 months of enrollment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jason W Bohland, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: