NCT06458153

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. 1.What regions of the brain's sensory systems show changes in their activity related to speech?
  2. 2.To what extent do these regions help listeners detect and correct speech errors?
  3. 3.What is the role of the cerebellum (a part of the brain in the back of the head) in these activities?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
26mo left

Started May 2025

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
May 2025Jul 2028

First Submitted

Initial submission to the registry

June 3, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

May 27, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

3.1 years

First QC Date

June 3, 2024

Last Update Submit

June 10, 2025

Conditions

Keywords

fmrispeech productioncerebellumauditory-motor integrationspeech motor controlneuroimaging

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • BOLD responses to speech listening task

    One session lasting 2-3 hours, within 12 months of enrollment

  • BOLD responses to silent articulation task

    One session lasting 2-3 hours, within 12 months of enrollment

  • Speech formant frequencies

    First session lasting 2-3 hours, within 12 months of enrollment

  • Spontaneous Speech Synchronization Index

    First session lasting 2-3 hours, within 12 months of enrollment

  • Auditory acuity

    First session lasting 2-3 hours, within 12 months of enrollment

Study Arms (1)

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.

Behavioral: Neural responses to speech functional localizerBehavioral: Neural responses to silent articulationBehavioral: Neural responses to self vs. externally generated speechBehavioral: Event-related potentials for speechBehavioral: Neural responses to induced speech errorsBehavioral: Neural responses to sensory-motor adaptationBehavioral: Speech production behaviorsBehavioral: Auditory acuity testingBehavioral: Neural responses to learning a non-speech auditory motor behavior

Interventions

Measuring speech-related brain activity using fMRI during a speech listening task.

Speech behavior and functional imaging

Measuring speech-related brain activity using fMRI during a silent articulation task.

Speech behavior and functional imaging

Measuring speech-related brain activity using fMRI during self-generated vs. externally-generated speech.

Speech behavior and functional imaging

Measuring electroencephalography (EEG) based evoked potentials for self vs. externally generated speech

Speech behavior and functional imaging

Measuring speech-related brain activity using fMRI during conditions that induce auditory speech errors.

Speech behavior and functional imaging

Measuring brain activity using fMRI during a learning task with sustained altered auditory feedback.

Speech behavior and functional imaging

Behavioral measurements of speech during reading passages and words

Speech behavior and functional imaging

Measurements of auditory acuity during listening tasks.

Speech behavior and functional imaging

Mapping of brain areas using fMRI during learning of non-speech sound-evoking movements.

Speech behavior and functional imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Evoked Potentials

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cortical ExcitabilityElectrophysiological PhenomenaPhysiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jason W Bohland, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason W Bohland, Ph.D.

CONTACT

Alexander Ocampo, B.A.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 13, 2024

Study Start

May 27, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be made available as soon as possible or at the time of associated publication. The duration of preservation and sharing of the data will be a minimum of 7 years after the end of study funding.
Access Criteria
Individual-level raw MRI and EEG datasets (along with metadata necessary to replicate analyses) will be shared via OpenNeuro.org, an open access repository for sharing neuroimaging data in Brain Imaging Data Structure (BIDS) format. Where possible, behavioral and audio data will also be shared on OpenNeuro.org, made available in a different free repository (Open Science Framework), or made available upon request.
More information

Locations