Low Intensity Focused Ultrasound in ASD

NCT ID: NCT07225322

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active LIFU

Group Type EXPERIMENTAL

Active LIFU

Intervention Type DEVICE

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

Interventions

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Active LIFU

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

COBRE in Neurodevelopment and its Disorders (CNDD)

UNKNOWN

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Kevin Caulfield

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin Caulfield, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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MUSC Brain Stimulation Offices

Charleston, South Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Kevin Caulfield, PhD

Role: CONTACT

Phone: 843-792-1006

Email: [email protected]

Facility Contacts

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Kevin Caulfield, PhD

Role: primary

Other Identifiers

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5P20GM148302

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00146822

Identifier Type: -

Identifier Source: org_study_id