StutterNCT07180628
Organization and Development of Motor Cortical Circuits for Speech Production in Stuttering
A study testing Speech Production During functional magnetic resonance imaging (MRI) in people with Stutter and Stuttering, Adult, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stutter, Stuttering, Adult, Stuttering
- What is being tested?
- Speech Production During functional magnetic resonance imaging (MRI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are between the ages of 18-65 years
- Have otherwise normal speech, language, hearing and cognition
- Speak English as their primary language
- Currently stutter
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Emily Garnett, PhD, 734-232-3371, emilyog@umich.edu
Soo-Eun Chang, PhD
About this study
The overall objective of this study is to examine inter effector areas (IEAs) activity and functional connectivity during continuous speech production in stuttering adults.
- Conditions
- Stutter, Stuttering, Adult, Stuttering, Stuttering, Developmental
- Being tested
- Speech Production During functional magnetic resonance imaging (MRI)
- Keywords
- Magnetic Resonance Imaging (MRI) scans, Behavioral assessments
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Production During functional magnetic resonance imaging (MRI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stutter group | Experimental | Participants that stutter Receives: Behavioral: Speech Production During functional magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the speech task (5 runs, 8 minutes each) distributed across MRI Visits 1-6, up to 12 months from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start24 Apr 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutterStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There will be 50 adults that stutter that participate in this study with a goal of 33 evaluable.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Soo-Eun Chang, University of Michigan
- Investigators
- Soo-Eun Shang, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180628
- Sponsor's protocol ID
- HUM00269390
- Other IDs
- 1R01DC022763-01
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organization and Development of Motor Cortical Circuits for Speech Production in Stuttering
- ClinicalTrials.gov ID
- NCT07180628
- Acronym / sponsor ID
- HUM00269390
- Conditions
- Stutter, Stuttering, Adult, Stuttering, Stuttering, Developmental
- Keywords
- Magnetic Resonance Imaging (MRI) scans, Behavioral assessments
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to examine inter effector areas (IEAs) activity and functional connectivity during continuous speech production in stuttering adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There will be 50 adults that stutter that participate in this study with a goal of 33 evaluable.
| Arm | Type | Receives |
|---|---|---|
| Stutter group | Experimental | Behavioral: Speech Production During functional magnetic resonance imaging (MRI)Participants that stutter |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are between the ages of 18-65 years
- Have otherwise normal speech, language, hearing and cognition
- Speak English as their primary language
- Currently stutter
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech Production During functional magnetic resonance imaging (MRI)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. | Behavioural | Stutter group |
Primary outcome
Blood-Oxygen-Level-Dependent (BOLD) signal change during speaking
Time frame: During the speech task (5 runs, 8 minutes each) distributed across MRI Visits 1-6, up to 12 months from enrollment.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soo-Eun Shang, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Production During functional magnetic resonance imaging (MRI) in people with Stutter and Stuttering, Adult, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Garnett, PhD (734-232-3371, emilyog@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-Oxygen-Level-Dependent (BOLD) signal change during speaking (time frame: During the speech task (5 runs, 8 minutes each) distributed across MRI Visits 1-6, up to 12 months from enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.