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Not yet recruiting NCT07225322

Low Intensity Focused Ultrasound in ASD

Phase I Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active LIFU.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 13 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Low Intensity Focused Ultrasound in Autism Spectrum Disorder

Overview

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.

Interventions

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

Primary outcome measures

  • 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 outcome measures (3)
  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • MUSC Brain Stimulation Offices — Charleston

Identifiers

NCT: NCT07225322 · Pro00146822 · 5P20GM148302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗