NCT07225322

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 6, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

September 4, 2025

Last Update Submit

May 20, 2026

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

Study Arms (1)

Active LIFU

EXPERIMENTAL
Device: Active LIFU

Interventions

Active LIFUDEVICE

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

Active LIFU

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUSC Brain Stimulation Offices

Charleston, South Carolina, 29407, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Kevin Caulfield, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Caulfield, PhD

CONTACT

843-792-1006caulfiel@musc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 4, 2025

First Posted

November 6, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

US(1)