- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06458153
Imaging Speech in Neurotypical Adults and Individuals With Cerebellar Stroke
High-resolution Functional Imaging of Speech-induced Sensory Modulation
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:
- What regions of the brain's sensory systems show changes in their activity related to speech?
- To what extent do these regions help listeners detect and correct speech errors?
- 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).
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Neural responses to speech functional localizer
- Behavioral: Neural responses to silent articulation
- Behavioral: Neural responses to self vs. externally generated speech
- Behavioral: Event-related potentials for speech
- Behavioral: Neural responses to induced speech errors
- Behavioral: Neural responses to sensory-motor adaptation
- Behavioral: Speech production behaviors
- Behavioral: Auditory acuity testing
- Behavioral: Neural responses to learning a non-speech auditory motor behavior
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jason W Bohland, Ph.D.
- Phone Number: 412-383-3416
- Email: j.bohland@pitt.edu
Study Contact Backup
- Name: Alexander Ocampo, B.A.
- Email: amo104@pitt.edu
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- Recruiting
- University of Pittsburgh
-
Contact:
- Jason Bohland, Ph.D.
- Phone Number: 412-383-3416
- Email: j.bohland@pitt.edu
-
Contact:
- Alexander Ocampo, BA
- Email: amo104@pitt.edu
-
Principal Investigator:
- Jason W Bohland, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Speech behavior and functional imaging
Assessing the neural correlates of speaking-induced sensory modulation in all three cohorts using behavior and neuroimaging tasks in up to 6 sessions.
|
Measuring speech-related brain activity using fMRI during a speech listening task.
Measuring speech-related brain activity using fMRI during a silent articulation task.
Measuring speech-related brain activity using fMRI during self-generated vs. externally-generated speech.
Measuring electroencephalography (EEG) based evoked potentials for self vs. externally generated speech
Measuring speech-related brain activity using fMRI during conditions that induce auditory speech errors.
Measuring brain activity using fMRI during a learning task with sustained altered auditory feedback.
Behavioral measurements of speech during reading passages and words
Measurements of auditory acuity during listening tasks.
Mapping of brain areas using fMRI during learning of non-speech sound-evoking movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The dependent variables (across voxels) are blood oxygenated level dependent fMRI measurements made during task performance.
We will contrast measured activations in regions of interest for the LISTEN-SELF vs. PRODUCE and LISTEN-OTHER vs. PRODUCE conditions.
Encoding models will predict activity in regions-of-interest (ROIs) based on a set of speech features.
|
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
|
The dependent variables (across voxels) are blood oxygenated level dependent fMRI measurements made during task performance.
We will contrast measured activations in regions of interest for responses to auditory stimuli across conditions (e.g., SPEAK, REHEARSE, PLAN, SILENT).
|
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
|
The dependent variables are evoked responses, aligned to sound onset, measured with EEG during task performance.
We will contrast evoked responses across conditions (e.g., TALK, LISTEN).
|
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
|
The dependent variables (across voxels) are blood oxygenated level dependent fMRI measurements made during task performance.
We will determine activations in regions of interest that correlate with applied perturbations during speech.
We will also compare SPEAK vs. LISTEN activations in perturbed and unperturbed conditions.
|
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
|
The dependent variables (across voxels) are blood oxygenated level dependent fMRI measurements made during task performance.
We will contrast measured activations in regions of interest for responses during the HOLD and BASELINE phases of the adaptation paradigm.
We will determine areas where activation is associated with changes in formant frequencies in early and late windows in speech recordings.
|
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
|
The dependent variables (across voxels) are blood oxygenated level dependent fMRI measurements made during task performance.
We will contrast measured activations in regions of interest for responses during PRESS trials across runs.
We will contrast LISTEN vs. PRESS trials to measure motor induced sensory modulation.
|
One session lasting 2-3 hours, within 12 months of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BOLD responses to speech listening task
Time Frame: One session lasting 2-3 hours, within 12 months of enrollment
|
The dependent variables (across voxels) are blood oxygenated level dependent fMRI measurements made during task performance.
We will contrast measured activations for the SPEECH vs. signal correlated noise (SCN) and SPEECH vs. SILENT conditions.
|
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
|
The dependent variables (across voxels) are blood oxygenated level dependent fMRI measurements made during task performance.
We will contrast measured activations for silent articulation vs. a resting baseline condition.
|
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
|
We will measure participant-specific phonetic variables (formant frequencies) based on participant speech from reading passages and word production.
|
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
|
We will measure the Spontaneous Speech Synchronization Index based on behavioral speech data.
|
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
|
We will measure auditory acuity (just noticeable difference) for changes in formant frequencies based on behavioral speech samples.
|
First session lasting 2-3 hours, within 12 months of enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason W Bohland, Ph.D., University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY23070083
- 1R01DC020963-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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