Stuttering, ChildhoodNCT05668923
Speech Signals in Stuttering
A study testing Speech sound stimulation in people with Stuttering, Childhood, run by University of Pittsburgh at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Childhood
- What is being tested?
- Speech sound stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Sep 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48105
Emily Garnett, PhD, CCC-SLP, emilyog@med.umich.edu
Soo-Eun Chang, PhD, CCC-SLP
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Brittany Coleman, MS, CCC-SLP, 412-710-6028, bmc162@pitt.edu
Amanda Hampton Wray, PhD, CCC-SLP
About this study
Official title: Neural Processing of Speech Signals in Children Who Stutter
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.
Read the detailed description
The study will evaluate the integrity of neural processes underlying speech sound encoding and the ways in which these processes are modulated by task demands using neuroimaging and computational modeling.
Age-appropriate standardized tests for assessing speech, language, and cognitive skills will be administered by a certified speech language pathologist or trained lab member.
The investigators will also measure electroencephalography (EEG) via frequency following responses (FFRs) and temporal response functions (TRFs) while children complete speech-sound tasks of varying difficulty including syllable listening and identification and continuous speech narrative comprehension tasks. Both tasks will be presented in both quiet and in background noise. EEG signals will be collected using Ag-AgCl scalp electrodes, and responses will be recorded at a sampling rate of 25 kHz using Brain Vision Recorder (Brain Products, Gilching, Germany).
The investigators will also leverage functional MRI (fMRI) to assess multiple neural systems underlying speech sound processing in children who stutter in a 3T scanner. Employing similar speech-sound tasks in the same participants as the EEG tasks will allow for quantifying neural activations and representations in auditory, speech motor articulatory, and attention networks during simple and complex speech tasks. A series of MRI scans will be recorded to provide data regarding the participant's brain anatomy. These scans will be analyzed on their own and also used in combination with functional scans. All participants will be screened for metal and other objects that are not appropriate for the MRI scanner room. Participants will be given earplugs and/or headphones to wear.
- Conditions
- Stuttering, Childhood
- Being tested
- Speech sound stimulation
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech sound stimulationBehavioural
Behavioral-, electrophysiological-, and magnetic resonance imaging-based speech sound testing
| Study group | Role | What they receive |
|---|---|---|
| Speech sound stimulation | Experimental | Speech sound stimulation via behavioral, electrophysiological, and magnetic resonance imaging-based tasks Receives: Behavioral: Speech sound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 Session (up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start21 Sep 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stuttering, ChildhoodStudies 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
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Institute on Deafness and Other Communication Disorders (NIDCD), Northwestern University
- Responsible party
- Principal investigator, Amanda Hampton Wray, University of Pittsburgh
- Investigators
- Amanda Hampton Wray, PhD, CCC-SLP, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668923
- Sponsor's protocol ID
- STUDY21120103
- Other IDs
- 1R01DC019904-01
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Processing of Speech Signals in Children Who Stutter
- ClinicalTrials.gov ID
- NCT05668923
- Acronym / sponsor ID
- STUDY21120103
- Conditions
- Stuttering, Childhood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Michigan, National Institute on Deafness and Other Communication Disorders (NIDCD), Northwestern University
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will evaluate the integrity of neural processes underlying speech sound encoding and the ways in which these processes are modulated by task demands using neuroimaging and computational modeling.
Age-appropriate standardized tests for assessing speech, language, and cognitive skills will be administered by a certified speech language pathologist or trained lab member.
The investigators will also measure electroencephalography (EEG) via frequency following responses (FFRs) and temporal response functions (TRFs) while children complete speech-sound tasks of varying difficulty including syllable listening and identification and continuous speech narrative comprehension tasks. Both tasks will be presented in both quiet and in background noise. EEG signals will be collected using Ag-AgCl scalp electrodes, and responses will be recorded at a sampling rate of 25 kHz using Brain Vision Recorder (Brain Products, Gilching, Germany).
The investigators will also leverage functional MRI (fMRI) to assess multiple neural systems underlying speech sound processing in children who stutter in a 3T scanner. Employing similar speech-sound tasks in the same participants as the EEG tasks will allow for quantifying neural activations and representations in auditory, speech motor articulatory, and attention networks during simple and complex speech tasks. A series of MRI scans will be recorded to provide data regarding the participant's brain anatomy. These scans will be analyzed on their own and also used in combination with functional scans. All participants will be screened for metal and other objects that are not appropriate for the MRI scanner room. Participants will be given earplugs and/or headphones to wear.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Speech sound stimulation | Experimental | Behavioral: Speech sound stimulationSpeech sound stimulation via behavioral, electrophysiological, and magnetic resonance imaging-based tasks |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech sound stimulationBehavioral-, electrophysiological-, and magnetic resonance imaging-based speech sound testing | Behavioural | Speech sound stimulation |
Primary outcome
Speech Sound Identification
Time frame: 1 Session (up to 2 hours)
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.
Frequency Following Responses (EEG)
Time frame: 1 Session (up to 30 minutes)
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.
Temporal Response Functions (EEG)
Time frame: 1 Session (up to 1 hour)
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.
Blood-oxygen level dependent activation (functional magnetic resonance imaging)
Time frame: 1 Session (up to 2 hours)
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.
Multi-voxel pattern analysis (functional magnetic resonance imaging)
Time frame: 1 Session (up to 2 hours)
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.
Psychophysiological Interactions
Time frame: 1 Session (up to 2 hours)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Hampton Wray, PhD, CCC-SLP principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech sound stimulation in people with Stuttering, Childhood, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany Coleman, MS, CCC-SLP (412-710-6028, bmc162@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Sound Identification (time frame: 1 Session (up to 2 hours)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.