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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07668882
Status
Not Yet Recruiting

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Conditions

  • Developmental Stuttering
  • Stuttering

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • High DC LIFU — DEVICE
    Stimulation parameters and target location. Stimulation will be delivered using the BrainSonix BXPulser 10002 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 — DEVICE
    Stimulation parameters and target location. Stimulation will be delivered using the BrainSonix BXPulser 10002 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 targeting anterior nucleus of thalamus (ANT) as the sham control with previous literature utilizing ANT-LIFU as a non-motor thalamus modulation.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: High DC LIFU then Sham
  • Sham Comparator: Sham then High DC LIFU

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Hasini Weerathunge, Ph.D.
[email protected]
734-232-5748
Hasini Weerathunge,, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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