Imaging Speech in Neurotypical Adults and Individuals With Cerebellar Stroke

Stroke Clinical Trial

Official title:

High-resolution Functional Imaging of Speech-induced Sensory Modulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458153
• Other study ID #: STUDY23070083
• Secondary ID: 1R01DC020963-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2028

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: Jason W Bohland, Ph.D.
• Phone: 412-383-3416
• Email: j.bohland[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 disease, injury, or impairment

• Hearing loss, defined by pure tone thresholds >25 decibels (dB) hearing level (HL) at octave frequencies between 250-8000 Hz

• Clinically diagnosed with or treated for a neuropsychiatric 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 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

• Hearing loss, defined by pure tone thresholds >50 dB HL at octave frequencies between 250-4000 Hz

• Clinically diagnosed with or treated for a neuropsychiatric disorder

• Head circumference greater than 60cm or weight greater than 300 pounds

• History of 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 disease, injury, or impairment

• Hearing loss, defined by pure tone thresholds >50 dB HL at octave frequencies between 250-4000 Hz

• Clinically diagnosed with or treated for a neuropsychiatric 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 claustrophobia

• Currently pregnant

Related Conditions & MeSH terms

• Cerebellum
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Deafness and Other Communication Disorders (NIDCD), Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One session lasting 2-3 hours, within 12 months of enrollment
Primary	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).	One session lasting 2-3 hours, within 12 months of enrollment
Primary	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).	One session lasting 2-3 hours, within 12 months of enrollment
Primary	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.	One session lasting 2-3 hours, within 12 months of enrollment
Primary	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.	One session lasting 2-3 hours, within 12 months of enrollment
Primary	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.	One session lasting 2-3 hours, within 12 months of enrollment
Secondary	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.	One session lasting 2-3 hours, within 12 months of enrollment
Secondary	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.	One session lasting 2-3 hours, within 12 months of enrollment
Secondary	Speech formant frequencies	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
Secondary	Spontaneous Speech Synchronization Index	We will measure the Spontaneous Speech Synchronization Index based on behavioral speech data.	First session lasting 2-3 hours, within 12 months of enrollment
Secondary	Auditory acuity	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