NCT05668923

Brief Summary

The purpose of this research study is to understand how speech and language are processed in the brain. This study will provide information that may help with the understanding how speech and language are processed in children and whether there may be differences between children who stutter and children who do not stutter. This project will evaluate these neural processes for speech signals in children who stutter and control subjects through a battery of behavioral speech and language tests, electroencephalography-based (EEG) tasks, functional magnetic resonance imaging (fMRI), and computational modeling.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Sep 2022Dec 2027

Study Start

First participant enrolled

September 21, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

5.2 years

First QC Date

December 2, 2022

Last Update Submit

September 8, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Speech Sound Identification

    Behavioral responses will be measured for the syllable identification task in quiet and in the presence of background noise. Children will respond as quickly as possible to identify which speech sound they heard. Within and between group analyses will be conducted between children who stutter and control subjects. Drift diffusion models (DDMs) will be used to aggregate the behavioral responses of accuracy and reaction time to evaluate bias toward more accurate or faster responses as well as change in response behaviors over time in each group.

    1 Session (up to 2 hours)

  • Frequency Following Responses (EEG)

    Frequency following responses (FFRs) will be collected and used to quantify neural encoding of fast temporal cues in auditory stimuli, including speech sounds. FFRs (70-1500 Hz) will be elicited by syllables. FFRs will be elicited in quiet conditions and in the presence of a competing background story. FFRs will be measured for magnitude. Decoding of FFRs elicited by syllables using support vector machine classifiers will be analyzed. Within and between group analyses will be conducted between children who stutter and control subjects.

    1 Session (up to 30 minutes)

  • Temporal Response Functions (EEG)

    Temporal response function (TRFs) analysis directly compares a continuously varying stimulus, such as continuous speech, to EEG data. The relationship between the continuous speech and EEG signals will be estimated as a continuous wave describing how a change in a continuous speech feature relates to changes in the EEG signal. The EEG data predicted by the TRF are compared to the real, observed EEG data via correlation, resulting in a measure of fitness (Pearson's r) for how well the stimulus explains the observed neural activity. Multivariate linear ridge regression using leave-one-out-cross validation method, to prevent over-fitting the data, will be utilized to compare the predicted and obtained EEG. Higher correlations between the predicted and obtained EEG reflect better cortical encoding of the speech envelope. Within and between group analyses will be conducted between children who stutter and control subjects.

    1 Session (up to 1 hour)

  • Blood-oxygen level dependent activation (functional magnetic resonance imaging)

    Brain activation patterns indexed by blood-oxygen level dependent (BOLD) fMRI signals will be analyzed. BOLD responses will be estimated separately for each participant for each functional task. Study-level outcomes include main effects of group (children who stutter vs. controls), group by region interactions, and group by network (auditory, speech motor, and attention) interactions. Drift diffusion models (DDMs) will be used to aggregate the behavioral responses of accuracy and reaction time (e.g. during the categorization the sounds such as /ba/ or /da/) to evaluate bias toward more accurate or faster responses as well as change in response behaviors over time in each group.

    1 Session (up to 2 hours)

  • Multi-voxel pattern analysis (functional magnetic resonance imaging)

    Multi-voxel pattern analysis (MVPA) is a machine learning analysis technique that aims to quantify spatially distributed neural representations across ensembles of voxels. MVPA will be used to determine the neural activity patterns that contain predictive information about the syllables (e.g. /ba/, da/) in the tasks in quiet and with background noise. Extracted BOLD parameter estimates for each syllable will be entered into the analysis. Participant specific classification cross-validation accuracies (per pre-determined regions of interest) will be contrasted between conditions to determine regions of interest in which representations are enhanced or degraded by increasing task demands. Regions with significant group-level classification accuracies in each task, as well as regions of interest showing task-dependent changes in classification accuracies, will be established by permutation testing for each region of interest for each participant.

    1 Session (up to 2 hours)

  • Psychophysiological Interactions

    Psychophysiological interaction (PPI) analyses evaluate task-dependent interactions between brain regions. Each pre-determined region of interest will serve as a seed region. For each target region (all other regions of interest), a general linear model will be used to estimate the interaction of task-related hemodynamic effects and the effects that are linearly related to the time-series of the seed region. Significant interactions reflect regions for which the effective connectivity with the seed-region changes as a function of task condition (i.e., indicating regions that are preferentially coupled for a specific task). Study-level outcomes will assess main effects of group (children who stutter vs controls), group by region interactions, and group by network (auditory, speech motor, attention) interactions.

    1 Session (up to 2 hours)

Study Arms (1)

Speech sound stimulation

EXPERIMENTAL

Speech sound stimulation via behavioral, electrophysiological, and magnetic resonance imaging-based tasks

Behavioral: Speech sound stimulation

Interventions

Behavioral-, electrophysiological-, and magnetic resonance imaging-based speech sound testing

Speech sound stimulation

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Speaks English as primary language
  • Language abilities within the typical range
  • Cognitive abilities within the typical range
  • No contraindications for MRI
  • Presence of developmental stuttering (onset in childhood)
  • No history of other communication disorder
  • No family history of stuttering
  • No history of other communication disorders (e.g., hearing impairment, language impairment, cognitive impairment/injury)

You may not qualify if:

  • Taking medication that alters neural function
  • Cognitive skills below the typical range
  • Major medical illness
  • Not a fluent speaker of English
  • Pregnant or possibly pregnant
  • Metal implants in your body (including pacemakers, neurostimulators, or other metal objects)
  • Shrapnel injuries
  • Ocular foreign bodies (e.g., metal shavings)
  • Metal piercings that cannot be removed for the scan
  • Tattoos containing iron or metal pigments
  • Prone to claustrophobia
  • For fMRI, those with head circumference greater than 60cm or whose weight is more than 300 pounds will be excluded due to the size of the fMRI magnet bore

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48105, United States

NOT YET RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amanda Hampton Wray, PhD, CCC-SLP

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Coleman, MS, CCC-SLP

CONTACT

Ashley Parker, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 30, 2022

Study Start

September 21, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The investigators will follow the guidelines set forth by the Open Knowledge International, which is a global non-profit organization that advocates for open science and open data. Our objectives in data sharing are to provide free and open access to everyone, make data easily available in a format that is broadly accessible and ensures longevity.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will become available as soon as possible but no later than one year upon completion of the study
Access Criteria
Our data will be made publicly available as soon as possible online to make it easily and widely accessible.

Locations