Low-Intensity Focused Ultrasound for Stuttering
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to help people who stutter using low-intensity focused ultrasound (LIFU). LIFU is a gentle, non-invasive sound technique designed to enhance the brain's speech processing. Researchers aim to assess how this treatment affects speech fluency and brain activity related to speaking. Individuals who currently stutter, speak English, and have not received stuttering treatment in the past year might be suitable candidates.
As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in speech therapy.
Will I have to stop taking my current medications?
If you are currently using antipsychotic medications for a primary psychotic disorder or bipolar disorder, mood stabilizers, or benzodiazepines, you may need to stop taking them to participate in the trial. However, low-dose use of certain antipsychotics for depression or anxiety is allowed if your condition is stable.
What prior data suggests that this low-intensity focused ultrasound technique is safe for treating stuttering?
Studies have shown that low-intensity focused ultrasound (LIFU) is generally safe for humans. Research indicates that people tolerate LIFU well, with no serious side effects reported. This technique uses gentle sound waves to enhance communication between brain areas and is both non-invasive and mild.
For example, one study found no serious brain injury or harmful effects from LIFU. Another study reported that LIFU is safe, making it promising for treating various conditions. Participants in these studies experienced either mild or no side effects.
Overall, the evidence suggests LIFU is safe and well-tolerated, making it a potential option for those exploring new treatment options.12345Why are researchers excited about this trial?
Researchers are excited about Low-Intensity Focused Ultrasound (LIFU) for stuttering because it offers a non-invasive approach that could address the condition's neurological roots. Unlike traditional speech therapy, which focuses on behavioral changes, or pharmacological treatments that may have side effects, LIFU targets specific brain regions with sound waves, potentially leading to more precise and effective results. This technique could open up a new frontier in stuttering treatment by directly influencing brain activity, offering hope for improved fluency without the need for medication or intensive therapy sessions.
What evidence suggests that low-intensity focused ultrasound is effective for stuttering?
This trial will compare the effects of Low-Intensity Focused Ultrasound (LIFU) on stuttering. Participants will receive either high DC LIFU followed by a sham treatment or a sham treatment followed by high DC LIFU. Studies have shown that LIFU can help people who stutter speak more fluently. After treatment, participants experienced less physical tension and gained better control over their speech. Brain activity also changed, enabling different brain areas to communicate more effectively. These changes suggest that LIFU could be a promising tool for managing stuttering by targeting specific brain regions involved in speech. While more research is needed, these initial findings offer hope for those seeking new stuttering treatments.678910
Who Is on the Research Team?
Hasini Weerathunge, Ph.D.
Principal Investigator
University of Michigan
Soo-Eun Chang, Ph.D.
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for people who have persistent developmental stuttering. Participants should not have any conditions or factors that would make it unsafe for them to receive noninvasive brain stimulation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline behavioral and speech assessments, MRI for stimulation target localization, and fMRI for brain connectivity assessment
Treatment
Participants receive both active and sham LIFU stimulation targeting the VIM thalamic nucleus, with concurrent and pre/post behavioral tasks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low-Intensity Focused Ultrasound (LIFU)
Trial Overview
The study is testing a gentle, noninvasive brain stimulation called low-intensity focused ultrasound (LIFU) compared to a sham (inactive) procedure, to see if LIFU can safely help with stuttering.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Michigan Pioneer Fellowship
Collaborator
Citations
The efficacy and safety of low-intensity focused ultrasound ...
Based on the above, this study aims to evaluate the efficacy and safety of LIFUP as a potential neuromodulatory treatment. Another major focus ...
The application of non-invasive neuromodulation in stuttering
Post-treatment improvements included increased speech fluency and reduced physical tensions. The results of EEG recordings indicated activity shifting from ...
A Comprehensive Review of Low-Intensity Focused ... - PMC
In this study, we provide a review of the most recent LIFU literature covering three key domains: 1) the history of focused ultrasound ...
NCT05147142 | Low Intensity Focused Ultrasound: a New ...
In this study, the investigators will test if this technique can be used to change brain activity in areas that are connected to depression and anxiety ...
The therapeutic potential of low-intensity focused ...
The current research examines LIFU's efficacy in reducing cravings and withdrawal symptoms. LIFU shows promise for reducing cravings, modulating reward ...
Safety of Clinical Ultrasound Neuromodulation - PMC - NIH
Transcranial ultrasound holds much potential as a safe, non-invasive modality for navigated neuromodulation, with low-intensity focused ultrasound (FUS) and ...
Motor and Non-Motor Effects of Low-Intensity Focused ...
LIFU induces reversible effects with a favorable safety profile, making it a promising candidate for non-invasive neuromodulation in movement disorders.
Low Intensity Focused Ultrasound for Non-invasive and ...
The above studies provide preliminary evidence of safety, as no serious adverse events or brain injury were described.
LIFU for Anxiety · Info for Participants · Clinical Trial 2026
Research has shown that Low-Intensity Focused Ultrasound (LIFU) is generally safe. Studies have found that people tolerate LIFU well. For instance, one study ...
Examination of low-intensity focused ultrasound ...
Conclusions LIFU to M1 in humans, in the range employed, either conferred inhibition or had no effect. Significant excitation was not observed.
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