NCT05286151

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jul 2022Jan 2027

First Submitted

Initial submission to the registry

March 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 23, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

4.5 years

First QC Date

March 9, 2022

Last Update Submit

October 21, 2025

Conditions

Stuttering, ChildhoodStuttering

Keywords

RhythmTemporal processingHealthy childrenSpeech disordersTiming

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Children who stutter

EXPERIMENTAL

Children who stutter

Behavioral: Rhythm discrimination

Children who do not stutter

EXPERIMENTAL

Children who do not stutter

Behavioral: Rhythm discrimination

Interventions

Rhythm discriminationBEHAVIORAL

Participants will complete a rhythm discrimination task once per year for 3 years.

Children who do not stutterChildren who stutter

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • English as primary language
  • Current or past stuttering diagnosis
  • English as primary language

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

StutteringSpeech Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Soo-Eun Chang, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo-Eun Chang, PhD

CONTACT

734-232-0300sooeunc@umich.edu

Emily Garnett, PhD

CONTACT

734-232-3371emilyog@umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 18, 2022

Study Start

July 23, 2022

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)