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

NCT07668882 | Not Yet Recruiting FDA Device

• 1 other identifier: HUM00274381
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Low Intensity Focused Ultrasound; Thalamus; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Percentage of stuttered syllables produced during speech sample

  The study will calculate the percentage of stuttered syllables (out of total syllables) in two speech samples (one before LIFU and one sample after LIFU) per each stimulation session. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering). Two samples are collected during session 1 and two samples are collected during session 2. An additional baseline sample is collected at the baseline session (on a separate day before the two stimulation sessions).

  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.

Secondary Outcomes (2)

• Stop signal response time (SSRT)

  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.

• Rhythm discrimination score (d')

  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.

Study Arms (2)

High DC LIFU then Sham

EXPERIMENTAL

Device: High DC LIFU; Device: Sham

Sham then High DC LIFU

SHAM COMPARATOR

Device: High DC LIFU; Device: Sham

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.

High DC LIFU then Sham; Sham then High DC LIFU

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.

High DC LIFU then Sham; Sham then High DC LIFU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Michigan Pioneer Fellowship: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hasini Weerathunge, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Soo-Eun Chang, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasini Weerathunge, Ph.D.

CONTACT

734-232-5748; weerathh@umich.edu

Soo-Eun Chang, Ph.D.

CONTACT

734-232-0300; sooeunc@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The Speech-Language Pathologist (SLP) conducting and scoring the speech samples to determine stuttering severity will be blind to the condition. A second SLP will score a subset of the speech samples to document reliability. The BrainSonix BXPulser 10002 brain stimulation system does not contain a blinded mode for double blinding. 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. A study team member not directly involved in any participant interaction or data analysis will randomize sessions and assign sham vs active sessions accordingly.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow, Psychiatry, Medical School

Model Details: This is a two-period, two-sequence crossover design. All participants receive both active LIFU and sham stimulation across two sessions. Participants randomized to Arm 1 receive High duty cycle (DC) LIFU in Session 1 followed by Sham in Session 2; those randomized to Arm 2 receive Sham in Session 1 followed by High DC LIFU in Session 2. The order is counterbalanced across participants to control for order effects. Participants also complete a baseline session where a T1 MRI structural image will be collected for VIM-LIFU targeting, and baseline versions of the outcome measures will also be collected.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)