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Network Connectivity and Temporal Processing in Adolescents Who Stutter

Primary Purpose

Stuttering, Childhood, Stuttering

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rhythm discrimination
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stuttering, Childhood focused on measuring Rhythm, Temporal processing, Healthy children, Speech disorders, Timing

Eligibility Criteria

9 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Children who stutter

Children who do not stutter

Arm Description

Children who stutter

Children who do not stutter

Outcomes

Primary Outcome Measures

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)).
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)).
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)).

Secondary Outcome Measures

Full Information

First Posted
March 9, 2022
Last Updated
June 29, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05286151
Brief Title
Network Connectivity and Temporal Processing in Adolescents Who Stutter
Official Title
Subcortical Network Connectivity and Temporal Processing in Children With Persistent and Recovered Stuttering
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Childhood, Stuttering
Keywords
Rhythm, Temporal processing, Healthy children, Speech disorders, Timing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children who stutter
Arm Type
Experimental
Arm Description
Children who stutter
Arm Title
Children who do not stutter
Arm Type
Experimental
Arm Description
Children who do not stutter
Intervention Type
Behavioral
Intervention Name(s)
Rhythm discrimination
Intervention Description
Participants will complete a rhythm discrimination task once per year for 3 years.
Primary Outcome Measure Information:
Title
Rhythm discrimination (d')
Description
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)).
Time Frame
Year 1
Title
Rhythm discrimination (d')
Description
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)).
Time Frame
Year 2
Title
Rhythm discrimination (d')
Description
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)).
Time Frame
Year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo-Eun Chang, PhD
Phone
734-232-0300
Email
sooeunc@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Garnett, PhD
Phone
734-232-3371
Email
emilyog@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-Eun Chang, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Eun Chang, PhD
Phone
734-232-0300
Email
sooeunc@umich.edu
First Name & Middle Initial & Last Name & Degree
Soo-Eun Chang, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Network Connectivity and Temporal Processing in Adolescents Who Stutter

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