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Not yet recruitingNCT07225322Updated May 22, 2026

Low Intensity Focused Ultrasound in ASD

A Phase 1 interventional study of Active LIFU in Autism Spectrum Disorder, sponsored by Medical University of South Carolina. Not yet recruiting at 1 site in United States. Open to participants aged 13 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Medical University of South Carolina · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
13 Years to 25 Years
Sex
All
01

Study summary

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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Conditions studied

  • Autism Spectrum Disorder
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In context

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's planned enrollment of 20 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Active LIFU

    Device: Active LIFU

Interventions

  • DeviceActive LIFU

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

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What researchers measure

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)

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Study locations

1 site
  • MUSC Brain Stimulation Offices
    Charleston, South Carolina 29407, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07225322
Lead sponsor
Medical University of South Carolina
Collaborators
National Institute of General Medical Sciences (NIGMS), COBRE in Neurodevelopment and its Disorders (CNDD)
Responsible party
Kevin Caulfield (Assistant Professor, Medical University of South Carolina) — Principal investigator
First posted
Nov 6, 2025
Start date
Jul 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
May 22, 2026

Study contacts

Kevin Caulfield, PhD
Contact
caulfiel@musc.edu
843-792-1006
Kevin Caulfield, PhD
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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