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NCT Number: NCT07225322

Low Intensity Focused Ultrasound in ASD

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MUSC Brain Stimulation Offices

Charleston, South Carolina, 29407, United States

Location contact

Kevin Caulfield, PhD

CONTACT

[email protected]

843-792-1006

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active LIFU

Device

In this open label study, all participants will receive active LIFU

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Caulfield, PhD

CONTACT

[email protected]

843-792-1006

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

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

Registry information

Official study title

Low Intensity Focused Ultrasound in Autism Spectrum Disorder

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 6, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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