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Clinical Trial NCT07225322 for Autism Spectrum Disorder is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Low Intensity Focused Ultrasound in ASD Phase 1 20 Non-Invasive Personalized Treatment

Not yet recruiting
Clinical Trial NCT07225322 is designed to study Treatment for Autism Spectrum Disorder. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 1 March 2026 until the study accrues 20 participants. Led by Medical University of South Carolina, this study is expected to complete by 1 September 2027. The latest data from ClinicalTrials.gov was last updated on 24 February 2026.
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.
Official Title

Low Intensity Focused Ultrasound in Autism Spectrum Disorder

Conditions
Autism Spectrum Disorder
Other Study IDs
NCT ID Number
NCT07225322
Start Date (Actual)
2026-03
Last Update Posted
2026-02-24
Completion Date (Estimated)
2027-09
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalActive LIFU
Active LIFU
In this open label study, all participants will receive active LIFU
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Penn Emotion Identification Task
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
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)
Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation)
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
13 Years
Eligible Sexes
All
  • 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

  • MRI or LIFU contraindications
  • Recent investigational drug/device use
  • Neurological illness (e.g., epilepsy, TBI)
  • Substance use disorder
  • Sensory/motor impairments preventing task completion
Medical University of South Carolina logoMedical University of South Carolina249 active studies to explore
  • National Institute of General Medical Sciences (NIGMS) logoNational Institute of General Medical Sciences (NIGMS)
  • COBRE in Neurodevelopment and its Disorders (CNDD) logoCOBRE in Neurodevelopment and its Disorders (CNDD)
Study Responsible Party
Kevin Caulfield, Principal Investigator, Assistant Professor, Medical University of South Carolina
Study Central Contact
Contact: Kevin Caulfield, PhD, 843-792-1006, [email protected]
1 Study Locations in 1 Countries

South Carolina

MUSC Brain Stimulation Offices, Charleston, South Carolina, 29407, United States
Kevin Caulfield, PhD, Contact, 843-792-1006, [email protected]