Low-Intensity Focused Ultrasound for Persistent Developmental Stuttering

This study is exploring if a non-invasive technique called Low-Intensity Focused Ultrasound (LIFU) can safely help adults who stutter. LIFU uses gentle sound waves to stimulate specific brain areas. Researchers want to see if this stimulation can improve speech fluency and how the brain works in people who stutter. You might be able to join if you are between 18 and 65 years old, speak English, currently stutter, and have normal language, hearing, and thinking abilities. The study will measure success by looking at the percentage of stuttered syllables you produce during speech samples. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This is a sham-controlled study, meaning some participants will receive the active LIFU treatment and others a placebo (sham) treatment. It plans to enroll 20 participants.
What's involved
You would attend multiple study visits, including baseline assessments, MRI scans, and sessions where you receive either active or sham LIFU stimulation. These sessions will involve speech production, reading, and rhythm perception tasks, over an estimated 2-3 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your speech will be assessed at baseline, and immediately before and after LIFU stimulation during two separate sessions, over an estimated 2-3 weeks.

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NCT07668882

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

Not Yet Recruiting
NAAges 18–65InterventionalTreatment
University of Michigan
~20 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:High DC LIFUSham

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of stuttered syllables produced during speech sample
Measured over Baseline, and immediately before and after LIFU stimulation during Stimulation Session 1 and Stimulation Session 2 (sessions occurring a minimum of 2 days apart and a maximum of 1 week apart), for a total of 5 assessments over an estimated 2-3 weeks.
Stuttering
Developmental Stuttering
1 sites across 1 states
Michigan1
  • Hasini Weerathunge, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Soo-Eun Chang, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Michigan

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Eligibility criteria

Inclusion

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

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.
  • Percentage of stuttered syllables produced during speech sampleBaseline, and immediately before and after LIFU stimulation during Stimulation Session 1 and Stimulation Session 2 (sessions occurring a minimum of 2 days apart and a maximum of 1 week apart), for a total of 5 assessments over an estimated 2-3 weeks.

    The study will calculate the percentage of stuttered syllables (out of total syllables) in two speech samples (one before LIFU and one sample after LIFU) per each stimulation session. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering). Two samples are collected during session 1 and two samples are collected during session 2. An additional baseline sample is collected at the baseline session (on a separate day before the two stimulation sessions).