Low Intensity Focused Ultrasound in ASD

Medical University of South Carolina (MUSC)

Status and phase: Not yet enrolling; Phase 1

Conditions: Autism Spectrum Disorder

Treatments: Device: Active LIFU

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07225322

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

Pro00146822

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 13 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Active LIFU

Experimental group

Treatment:

Device: Active LIFU