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Low Intensity Focused Ultrasound in ASD

Low Intensity Focused Ultrasound in Autism Spectrum Disorder

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07225322
Enrollment
20
Registered
2025-11-06
Start date
2026-07-01
Completion date
2027-12-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief 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.

Interventions

DEVICEActive LIFU

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

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
COBRE in Neurodevelopment and its Disorders (CNDD)
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 25 Years
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

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

Design outcomes

Primary

MeasureTime frame
Social Responsiveness Scale, Second Edition (SRS-2)Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation; Visit 8, within 1 month of last stimulation)

Secondary

MeasureTime frame
Penn Emotion Identification TaskBaseline (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 bandBaseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation)
Radiological MRI Safety Scans (T1, T2, diffusion scans, read for abnormalities)Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation)

Countries

United States

Contacts

CONTACTKevin Caulfield, PhD
caulfiel@musc.edu843-792-1006
PRINCIPAL_INVESTIGATORKevin Caulfield, PhD

Medical University of South Carolina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026