StrokeNCT06458153
Imaging Speech in Neurotypical Adults and Individuals With Cerebellar Stroke
A study testing Neural responses to speech functional localizer, Neural responses to silent articulation and Neural responses to self vs. externally generated speech in people with Stroke and Cerebellum, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebellum
- What is being tested?
- Neural responses to speech functional localizer, Neural responses to silent articulation and Neural responses to self vs. externally generated speech
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2025to Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohort 1 (neurotypical adults):
- Age 18-49
- Right-handed
- Native English speaker
- Cohort 2 (people with cerebellar lesions):
- Age 18 or older
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexander Ocampo, B.A. contact
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Jason Bohland, Ph.D., 412-383-3416, j.bohland@pitt.edu
Alexander Ocampo, BA, amo104@pitt.edu
About this study
Official title: 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).
Read the 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.
- Conditions
- Stroke, Cerebellum
- Being tested
- Neural responses to speech functional localizer, Neural responses to silent articulation, Neural responses to self vs. externally generated speech, Event-related potentials for speech, Neural responses to induced speech errors
- Keywords
- fmri, speech production, cerebellum, auditory-motor integration, speech motor control, neuroimaging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural responses to speech functional localizerBehavioural
Measuring speech-related brain activity using fMRI during a speech listening task.
Neural responses to silent articulationBehavioural
Measuring speech-related brain activity using fMRI during a silent articulation task.
Neural responses to self vs. externally generated speechBehavioural
Measuring speech-related brain activity using fMRI during self-generated vs. externally-generated speech.
Event-related potentials for speechBehavioural
Measuring electroencephalography (EEG) based evoked potentials for self vs. externally generated speech
Neural responses to induced speech errorsBehavioural
Measuring speech-related brain activity using fMRI during conditions that induce auditory speech errors.
Neural responses to sensory-motor adaptationBehavioural
Measuring brain activity using fMRI during a learning task with sustained altered auditory feedback.
Speech production behaviorsBehavioural
Behavioral measurements of speech during reading passages and words
Auditory acuity testingBehavioural
Measurements of auditory acuity during listening tasks.
Neural responses to learning a non-speech auditory motor behaviorBehavioural
Mapping of brain areas using fMRI during learning of non-speech sound-evoking movements.
| Study group | Role | What they receive |
|---|---|---|
| Speech behavior and functional imaging | Experimental | Assessing the neural correlates of speaking-induced sensory modulation in all three cohorts using behavior and neuroimaging tasks in up to 6 sessions. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygenation level dependent (BOLD) responses to self vs. externally generated speech
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.
Measured: One session lasting 2-3 hours, within 12 months of enrollment
BOLD responses related to pre-speech auditory modulation
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).
Measured: One session lasting 2-3 hours, within 12 months of enrollment
EEG responses to self vs. externally generated speech
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).
Measured: One session lasting 2-3 hours, within 12 months of enrollment
BOLD responses to induced auditory errors
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.
Measured: One session lasting 2-3 hours, within 12 months of enrollment
BOLD responses during adaptation to auditory perturbations
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.
Measured: One session lasting 2-3 hours, within 12 months of enrollment
BOLD responses during learning of non-speech auditory motor targets
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.
Measured: One session lasting 2-3 hours, within 12 months of enrollment
Secondary outcomes (5)
BOLD responses to speech listening task
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.
Measured: One session lasting 2-3 hours, within 12 months of enrollment
BOLD responses to silent articulation task
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.
Measured: One session lasting 2-3 hours, within 12 months of enrollment
Speech formant frequencies
We will measure participant-specific phonetic variables (formant frequencies) based on participant speech from reading passages and word production.
Measured: First session lasting 2-3 hours, within 12 months of enrollment
Spontaneous Speech Synchronization Index
We will measure the Spontaneous Speech Synchronization Index based on behavioral speech data.
Measured: First session lasting 2-3 hours, within 12 months of enrollment
Auditory acuity
We will measure auditory acuity (just noticeable difference) for changes in formant frequencies based on behavioral speech samples.
Measured: First session lasting 2-3 hours, within 12 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start27 May 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Jason Bohland, University of Pittsburgh
- Investigators
- Jason W Bohland, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458153
- Sponsor's protocol ID
- STUDY23070083
- Other IDs
- 1R01DC020963-01A1
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will produce behavioral, audio, electroencephalography (EEG), and structural and functional magnetic resonance imaging (MRI) data. Data will be de-identified (MRI images will be defaced and all identifiers will be scrubbed) and made available for sharing at the individual level using community accepted formats for data and metadata.