Ultrasound Treatment for Autism

Overseen By Kevin Caulfield, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical University of South Carolina

Disqualifiers: Epilepsy, TBI, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using low-intensity focused ultrasound (LIFU) to assist individuals with Autism Spectrum Disorder (ASD). The goal is to determine if this approach is safe and can improve behaviors and brain activity by targeting the thalamus. The study seeks participants diagnosed with ASD, aged 13 to 25, with a full-scale IQ over 70, who can communicate verbally, and have been on stable medication for at least a month. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

Do I need to stop my current medications for the trial?

The trial requires that your current medications be stable for at least one month before participating, so you won't need to stop taking them if they have been stable.

What prior data suggests that this ultrasound treatment is safe for individuals with Autism Spectrum Disorder?

Research on Low Intensity Focused Ultrasound (LIFU) remains in the early stages, so limited information exists on its effects on individuals with Autism Spectrum Disorder (ASD). However, LIFU has been tested in other studies and is generally considered safe. As a non-invasive procedure, it does not involve surgery or entering the body.

In studies on other conditions, LIFU was well-tolerated, with most participants not experiencing significant side effects. Some individuals might feel mild discomfort or warmth during the procedure, but serious issues are rare. Since LIFU is still under investigation for autism, participating in the trial could help researchers gather more data on its safety for this specific use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for autism?

Researchers are excited about Low Intensity Focused Ultrasound (LIFU) for autism because it offers a non-invasive approach that could directly modulate brain activity. Unlike current treatments, which often include behavioral therapies and medications targeting symptoms like irritability or hyperactivity, LIFU uses sound waves to target specific brain areas involved in autism. This precise targeting could potentially improve core symptoms of autism, such as communication and social interaction, with fewer side effects. The novel mechanism of using ultrasound waves to influence brain function is what makes this treatment stand out and holds promise for new therapeutic pathways.

What evidence suggests that this ultrasound treatment might be an effective treatment for autism?

Studies have shown that low-intensity focused ultrasound (LIFU), which participants in this trial will receive, might help improve symptoms in people with Autism Spectrum Disorder (ASD). In one case, LIFU improved social interaction and reduced repetitive behaviors. It also helped manage irritability by altering brain activity patterns. This non-invasive treatment targets the thalamus, a part of the brain that processes sensory and social information. Early research suggests that LIFU could be a promising new method to help individuals with ASD overcome some challenges. ^{1 2 3 4 6}

Who Is on the Research Team?

Kevin Caulfield, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with Autism Spectrum Disorder (ASD). Specific details about who can join are not provided, but typically participants must meet certain health criteria and be within a certain age range.

Inclusion Criteria

Full Scale IQ > 70

Verbal communication

I have been diagnosed with Autism Spectrum Disorder.

Exclusion Criteria

MRI or LIFU contraindications

Recent investigational drug/device use

Substance use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized, image-guided low intensity focused ultrasound (LIFU) targeting the thalamus

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after LIFU treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low Intensity Focused Ultrasound

Trial Overview The study is testing the safety and potential benefits of using low intensity focused ultrasound (LIFU) on the thalamus. It's non-invasive and looks at changes in behavior, brain imaging, and brain wave patterns after treatment.

How Is the Trial Designed?

Group I: Active LIFU Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

COBRE in Neurodevelopment and its Disorders (CNDD)

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07225322

NCT07225322 | Low Intensity Focused Ultrasound in ASD The study evaluates behavioral, neuroimaging, and electrophysiological outcomes following LIFU stimulation using a non-invasive device. Official ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12323716/

Case Report: Low-intensity transcranial focused ultrasound ... This case revealed that low-frequency tFUS improved social interaction and stereotypical behavior, alleviated irritable emotions by enhancing ROI-wise and pair- ...

3. ctv.veeva.com ctv.veeva.com/study/low-intensity-focused-ultrasound-in-asd

Low Intensity Focused Ultrasound in ASD - ClinicalTrials.Veeva The study evaluates behavioral, neuroimaging, and electrophysiological outcomes following LIFU stimulation using a non-invasive device.

4. trial.medpath.com trial.medpath.com/clinical-trial/e308a8a795c77568/nct07225322-low-intensity-focused-ultrasound-autism-spectrum-disorder

Low Intensity Focused Ultrasound in ASD - MedPath The study evaluates behavioral, neuroimaging, and electrophysiological outcomes following LIFU stimulation using a non-invasive device. Detailed Description.

5. magazine.ingentium.com magazine.ingentium.com/2025/11/08/low-intensity-focused-ultrasound-in-autism-spectrum-disorder/

Low Intensity Focused Ultrasound in Autism Spectrum ... The study evaluates behavioral, neuroimaging, and electrophysiological outcomes following LIFU stimulation using a non-invasive device. Concepts ...

6. withpower.com withpower.com/trial/phase-1-autism-spectrum-disorder-11-2025-78102

Ultrasound Treatment for Autism · Info for Participants This study investigates the safety and potential efficacy of personalized, image-guided low intensity focused ultrasound (LIFU) targeting the thalamus in ...