Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Noninvasive Thalamocortical Stimulation for Stuttering

Official title: Noninvasive Thalamocortical Neuromodulation With Low-Intensity Focused Ultrasound for Persistent Developmental Stuttering

Run by University of Michigan · NCT07668882 · Data updated 2026-11-12

This study tests whether mild, focused ultrasound to a brain area involved in speech can safely improve fluency in adults who stutter.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment20 (estimated)
SponsorUniversity of Michigan
Academic / other
Locations1 site (Ann Arbor, Michigan)
StatusRecruiting
StartedAugust 19, 2026
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedSeptember 15, 2026
Trial IDNCT07668882 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with persistent developmental stuttering, normal language/hearing, and no major medical or neurological conditions who speak English as their primary language.

Probably not a fit

Individuals with a history of seizures, certain medical or neurological illnesses, implanted devices, or unstable psychiatric conditions may not benefit and are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small, sham-controlled study to see if low-intensity focused ultrasound can safely modulate brain activity related to speech. Researchers will use MRI to locate the left ventral intermediate thalamus and deliver stimulation while participants perform speech and reading tasks. The study includes baseline assessments, MRI and fMRI, neuronavigation-guided stimulation, and both active and sham sessions to measure feasibility, safety, and potential effects on fluency. Participants will be adults with persistent developmental stuttering, with careful screening for language, hearing, and cognitive function. Outcomes focus on safety, targeting precision, and changes in speech-related brain connectivity and performance.

Why it matters

Potential benefit: If successful, this approach could offer a new noninvasive option to improve speech fluency for people who stutter.

How similar studies have gone: Prior noninvasive neuromodulation studies in related areas have shown feasibility and safety signals, though this exact approach is exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* have normal language, hearing and cognition
* speak English as their primary language
* currently stutter
* score at least 10 (very mild) on the Stuttering Severity Instrument (SSI-4) or exhibit greater than 3% stuttered syllables during at least one of the first 3 speech samples
* have not receive any treatment for stuttering within the past year

Exclusion Criteria:

* History of seizures
* Major medical or neurological illness (e.g., stroke, serious head trauma, brain infection, Parkinson's disease, etc.)
* History of closed head injury with loss of consciousness (e.g., concussion)
* Metal or electronic implants such as cochlear implants and pacemakers
* Braids or other hair styling that prevents direct access to the scalp (if removal not possible)
* Current or planned pregnancy
* Any active, unstable, or inadequately treated psychiatric condition, including but not limited to psychosis, active major depressive episode, bipolar disorder with recent mood episode, or current suicidal ideation.
* Current use of antipsychotic medications for treatment of a primary psychotic disorder or bipolar disorder; current use of mood stabilizers (e.g., lithium, valproate) or benzodiazepines. Low-dose adjunctive use of atypical antipsychotics (e.g., brexpiprazole, aripiprazole, quetiapine) for treatment-resistant depression or anxiety is not exclusionary if the participant's condition is stable per the existing ≥2-month stability criterion.
* Any condition or medication that lowers seizure threshold, consistent with standard practice across non-invasive brain stimulation protocols.

Note: participants who cannot undergo MRI may complete the other portions of the study. For participants who cannot undergo MRI can be targeted for LIFU stimulation using a standard T1 scan. Resting state fMRI measures taken before and after stimulation will also be omitted for these cases. But the behavioral and speech measures can still be completed to provide pre and post-stimulation variations.

Where it's running

  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting

Study contacts

  • Principal investigator: Hasini Weerathunge, Ph.D. — University of Michigan
  • Study coordinator: Hasini Weerathunge, Ph.D.
  • Email: weerathh@umich.edu
  • Phone: 734-232-5748

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.