Recruiting

LIFU

Sponsor:

University of Michigan

Code:

NCT07668882

Conditions

Stuttering

Developmental Stuttering

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

High DC LIFU

Sham

Study Details

Brief summary:

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.

Conditions

Stuttering

Developmental Stuttering

Study ID

NCT07668882

Start date

Aug 19, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High DC LIFU then Sham

sham comparator: Sham then High DC LIFU

Interventions

High DC LIFU

Stimulation parameters and target location. Stimulation will be delivered using the BrainSonix BXPulsar 1002 System (BrainSonix Corporation, Sherman Oaks, CA, USA). Sonication Parameters will be as follows. Fundamental frequency: 650 kHz; pulse repetition frequency: 10Hz; pulse duration: 100ms; DC: 70% (yielding pulse width of 70 ms); sonication duration: 30 s; inter-sonication interval: 30s; LIFU-ON epochs per block: 12 epochs (Jang et al., 2025). During active stimulation a total of 4.2 min stimulation will be applied across all LIFU-ON epochs. Both active and sham stimulation sessions will last \~12 mins each. The researchers will be targeting ventral intermediate nucleus (VIM) region of the thalamus for the active stimulation.

Sham

Stimulation parameters and target location. Stimulation will be delivered using the BrainSonix BXPulsar 1002 System (BrainSonix Corporation, Sherman Oaks, CA, USA). Sonication Parameters will be as follows. Fundamental frequency: 650 kHz; pulse repetition frequency: 10Hz; pulse duration: 100ms; DC: 70% (yielding pulse width of 70 ms); sonication duration: 30 s; inter-sonication interval: 30s; LIFU-ON epochs per block: 12 epochs (Jang et al., 2025). During sham stimulation a total of 4.2 min stimulation will be applied across all LIFU-ON epochs. Both active and sham stimulation sessions will last \~12 mins each. The researchers will be reversing the direction of the transducer placed on the head such that no active stimulation will be applied to the participant's head. But the neuronavigation procedures (targeting VIM) and stimulation parameters will be kept identical such that the participant experiences the same procedure across active and sham conditions.

Primary outcome measure

  • Percentage of stuttered syllables produced during speech sample [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Hasini Weerathunge, Ph.D.

734-232-5748weerathh@umich.edu

Soo-Eun Chang, Ph.D.

734-232-0300sooeunc@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Hasini Weerathunge, Ph.D.

734-232-5748weerathh@umich.edu

Principal Investigator:

Hasini Weerathunge,, Ph.D.

More Information

Sponsor

University of Michigan

Last update posted

Sep 15, 2026

Last verified

Aug, 2026

Keywords

  • Low Intensity Focused Ultrasound
  • Thalamus
  • Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.