NCT07180628

Brief Summary

The overall objective of this study is to examine inter effector areas (IEAs) activity and functional connectivity during continuous speech production in stuttering adults.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
35mo left

Started Apr 2026

Typical duration 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 Progress1%
Apr 2026Mar 2029

First Submitted

Initial submission to the registry

September 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

April 24, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

September 5, 2025

Last Update Submit

April 27, 2026

Conditions

StutterStuttering, AdultStutteringStuttering, Developmental

Keywords

Magnetic Resonance Imaging (MRI) scansBehavioral assessments

Outcome Measures

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).

    During the speech task (5 runs, 8 minutes each) distributed across MRI Visits 1-6, up to 12 months from enrollment.

Study Arms (1)

Stutter group

EXPERIMENTAL

Participants that stutter

Behavioral: Speech Production During functional magnetic resonance imaging (MRI)

Interventions

Speech Production During functional magnetic resonance imaging (MRI)BEHAVIORAL

Participants 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.

Stutter group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are between the ages of 18-65 years
  • Have otherwise normal speech, language, hearing and cognition
  • Speak English as their primary language
  • Currently stutter

You may not qualify if:

  • 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
  • Have metal or electronic implants (e.g., cochlear implants, pacemakers, etc.)
  • Are currently pregnant

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

Stuttering

Condition Hierarchy (Ancestors)

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

Study Officials

  • Soo-Eun Shang, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Garnett, PhD

CONTACT

734-232-3371emilyog@umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: There will be 50 adults that stutter that participate in this study with a goal of 33 evaluable.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 18, 2025

Study Start

April 24, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)