Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2022-09-21
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Speech sound stimulation
Speech sound stimulation via behavioral, electrophysiological, and magnetic resonance imaging-based tasks
Speech sound stimulation
Behavioral-, electrophysiological-, and magnetic resonance imaging-based speech sound testing
Interventions
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Speech sound stimulation
Behavioral-, electrophysiological-, and magnetic resonance imaging-based speech sound testing
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
5 Years
17 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Amanda Hampton Wray
Associate Professor
Principal Investigators
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Amanda Hampton Wray, PhD, CCC-SLP
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Michigan
Ann Arbor, Michigan, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY21120103
Identifier Type: -
Identifier Source: org_study_id
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