Clinical trial NCT05668923: Speech Signals in Stuttering
Official title: Neural Processing of Speech Signals in Children Who Stutter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stuttering, Childhood
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-12-30
Enrollment: 600
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Speaks English as primary language
* Language abilities within the typical range
* Cognitive abilities within the typical range
* No contraindications for MRI

Inclusion criteria for children who stutter:

* Presence of developmental stuttering (onset in childhood)
* No history of other communication disorder

Inclusion criteria for children who do not stutter:

* No family history of stuttering
* No history of other communication disorders (e.g., hearing impairment, language impairment, cognitive impairment/injury)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Speech Sound Identification
timeFrame: 1 Session (up to 2 hours)
measure: Frequency Following Responses (EEG)
timeFrame: 1 Session (up to 30 minutes)
measure: Temporal Response Functions (EEG)
timeFrame: 1 Session (up to 1 hour)
measure: Blood-oxygen level dependent activation (functional magnetic resonance imaging)
timeFrame: 1 Session (up to 2 hours)
measure: Multi-voxel pattern analysis (functional magnetic resonance imaging)
timeFrame: 1 Session (up to 2 hours)
measure: Psychophysiological Interactions
timeFrame: 1 Session (up to 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Amanda Hampton Wray, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: