Network Connectivity and Temporal Processing in Adolescents Who Stutter

Stuttering Clinical Trial

Official title:

Subcortical Network Connectivity and Temporal Processing in Children With Persistent and Recovered Stuttering

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286151
• Other study ID #: HUM00196133
• Secondary ID: 2R01DC011277
• Status: Recruiting
• Phase: N/A
• Start date: July 23, 2022
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: Soo-Eun Chang, PhD
• Phone: 734-232-0300
• Email: sooeunc[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Stuttering
• Stuttering, Childhood

Intervention

Behavioral:
• Rhythm discrimination
Participants will complete a rhythm discrimination task once per year for 3 years.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhythm discrimination (d')	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
Primary	Rhythm discrimination (d')	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
Primary	Rhythm discrimination (d')	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