- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05286151
Network Connectivity and Temporal Processing in Adolescents Who Stutter
October 21, 2025 updated by: Soo-Eun Chang, University of Michigan
Subcortical Network Connectivity and Temporal Processing in Children With Persistent and Recovered Stuttering
The specific purpose of this clinical trial is to compare performance on rhythm perception and production tasks between children who stutter and children who do not stutter.
The overall project also aims to investigate how performance on rhythm tasks may be related to brain activity (non-clinical trial).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants in the clinical trial portion of this study will complete rhythm discrimination and finger tapping experiments once a year for 3 years.
The study team will compare performance between groups.
Participants will also participate in the non-trial portion of the project that includes having magnetic resonance imaging (MRI) each year for 3 years.
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Soo-Eun Chang, PhD
- Phone Number: 734-232-0300
- Email: sooeunc@umich.edu
Study Contact Backup
- Name: Emily Garnett, PhD
- Phone Number: 734-232-3371
- Email: emilyog@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Soo-Eun Chang, PhD
- Phone Number: 734-232-0300
- Email: sooeunc@umich.edu
-
Principal Investigator:
- Soo-Eun Chang, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 9 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria Children who stutter:
- English as primary language
- Current or past stuttering diagnosis
Inclusion Criteria Children who do not stutter:
- English as primary language
Exclusion Criteria Children who stutter:
- Diagnosed/under treatment for any neurological or psychiatric conditions
- Head trauma with loss of consciousness
- Major medical illness
- Hearing loss- Language/motor delay (below -2 standard deviations on standardized assessments)
- Face, motor, or reflex abnormalities
Exclusion Criteria Children who do not stutter:
- Personal or family history of stuttering
- Diagnosed/under treatment for any neurological or psychiatric conditions
- Head trauma with loss of consciousness
- Major medical illness
- Hearing loss
- Language/motor delay (below -2 standard deviations on standardized assessments
- Face, motor, or reflex abnormalities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Children who stutter
|
Participants will complete a rhythm discrimination task once per year for 3 years.
|
|
Experimental: Children who do not stutter
|
Participants will complete a rhythm discrimination task once per year for 3 years.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rhythm discrimination (d')
Time Frame: Year 1
|
Performance on the rhythm discrimination task will be assessed using a signal detection analysis to distinguish between participants' ability to discriminate same and different rhythms from any general tendency to respond same or different.
Hit rates (HRs) and false alarm rates (FARs) will be obtained to calculate d' (a measure of sensitivity; determined by z(HR) - z(FAR)).
|
Year 1
|
|
Rhythm discrimination (d')
Time Frame: Year 2
|
Performance on the rhythm discrimination task will be assessed using a signal detection analysis to distinguish between participants' ability to discriminate same and different rhythms from any general tendency to respond same or different.
Hit rates (HRs) and false alarm rates (FARs) will be obtained to calculate d' (a measure of sensitivity; determined by z(HR) - z(FAR)).
|
Year 2
|
|
Rhythm discrimination (d')
Time Frame: Year 3
|
Performance on the rhythm discrimination task will be assessed using a signal detection analysis to distinguish between participants' ability to discriminate same and different rhythms from any general tendency to respond same or different.
Hit rates (HRs) and false alarm rates (FARs) will be obtained to calculate d' (a measure of sensitivity; determined by z(HR) - z(FAR)).
|
Year 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Soo-Eun Chang, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 23, 2022
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Study Registration Dates
First Submitted
March 9, 2022
First Submitted That Met QC Criteria
March 9, 2022
First Posted (Actual)
March 18, 2022
Study Record Updates
Last Update Posted (Estimated)
October 23, 2025
Last Update Submitted That Met QC Criteria
October 21, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00196133
- 2R01DC011277 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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