Organization and Development of Motor Cortical Circuits for Speech Production in Stuttering
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Michigan
About this trial
The overall objective of this study is to examine inter effector areas (IEAs) activity and functional connectivity during continuous speech production in stuttering adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are between the ages of 18-65 years
Have otherwise normal speech, language, hearing and cognition
Speak English as their primary language
Currently stutter
Disqualifiers
Have serious medical or neurological conditions (e.g., stroke, traumatic brain injury, Parkinson's disease, etc.)
Have had a closed head injury (e.g., concussion)
Have a reading disorder (e.g., dyslexia)
Have hearing loss
Trial design
Design model
Single group
Treatments tested in this trial
Speech Production During functional magnetic resonance imaging (MRI)
BehavioralParticipants will complete a speech production task with 2 conditions (stuttered, non-stuttered) while undergoing functional MRI to assess brain activity. Brain activity will be compared within subjects for the 2 conditions. The intervention is the combination of tasks delivered to all participants. The speaking task is the intervention (modifying agent) and the MRI is a measurement tool, not a therapeutic or modifying agent.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Stutter groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Blood-Oxygen-Level-Dependent (BOLD) signal change during speaking
The Blood-oxygen-level-dependent (BOLD) signal reflects changes in blood oxygenation levels that are associated with neural activity. It is measured using functional magnetic resonance imaging (fMRI) and reported in arbitrary units (a.u.). The BOLD response provides an indirect index of localized brain activity during task performance, with increased signal indicating greater activation in a given brain region relative to baseline or a comparison condition. In this study, BOLD signal differences will be compared within participants across two speech production tasks: (1) stuttered speech and (2) non-stuttered speech. Each participant will complete the speech task on several of the MRI visits, which varies per participant (total amount of time spent will be the same across participants).
Time frame
During the speech task (5 runs, 8 minutes each) distributed across MRI Visits 1-6, up to 12 months from enrollment.Sponsors and contacts
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University of Michigan
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov