Low Intensity Focused Ultrasound in ASD

May 20, 2026 updated by: Kevin Caulfield, Medical University of South Carolina

Low Intensity Focused Ultrasound in Autism Spectrum Disorder

This study investigates the safety and potential efficacy of personalized, image-guided low intensity focused ultrasound (LIFU) targeting the thalamus in individuals with Autism Spectrum Disorder (ASD). The study evaluates behavioral, neuroimaging, and electrophysiological outcomes following LIFU stimulation using a non-invasive device.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • MUSC Brain Stimulation Offices
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 13-25
  • Diagnosis of ASD (DSM-5)
  • Full Scale IQ > 70
  • Verbal communication
  • Stable medication for ≥1 month
  • Ability to consent or assent with guardian consent

Exclusion Criteria:

  • MRI or LIFU contraindications
  • Recent investigational drug/device use
  • Neurological illness (e.g., epilepsy, TBI)
  • Substance use disorder
  • Sensory/motor impairments preventing task completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active LIFU
Device: Active LIFU
In this open label study, all participants will receive active LIFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Social Responsiveness Scale, Second Edition (SRS-2)
Time Frame: Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation; Visit 8, within 1 month of last stimulation)
Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation; Visit 8, within 1 month of last stimulation)

Secondary Outcome Measures

Outcome Measure
Time Frame
Penn Emotion Identification Task
Time Frame: Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation; Visit 8, within 1 month of last stimulation)
Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation; Visit 8, within 1 month of last stimulation)
Electroencephalography (EEG) in the alpha (8-12Hz) frequency band
Time Frame: Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation)
Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation)
Radiological MRI Safety Scans (T1, T2, diffusion scans, read for abnormalities)
Time Frame: Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation)
Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute of General Medical Sciences (NIGMS)
COBRE in Neurodevelopment and its Disorders (CNDD)

Investigators

  • Principal Investigator: Kevin Caulfield, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 4, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Actual)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00146822
  • 5P20GM148302 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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