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

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

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Michigan Pioneer Fellowship

  collaborator UNKNOWN

• University of Michigan

  lead OTHER

Principal Investigators

• Hasini Weerathunge, Ph.D. · University of Michigan

• Soo-Eun Chang, Ph.D. · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-08-31

Completion

2027-08-31

FDA Device

Yes

Countries

• United States

Study Locations