💬In plain words
What the trial is, and whether it could suit you
This research is studying the use of low-intensity focused ultrasound (LIFU; a mild, noninvasive acoustic stimulation technique) in a small number of people to learn about its safety as a treatment for stuttering. LIFU is a small, safe sound signal that produces a gentle, pulsing flow of acoustic waves to help different parts of the brain communicate with each other. Researchers want to understand how the mild, non-invasive brain stimulation affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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