Autism Spectrum DisorderPhase 1NCT07225322
Low Intensity Focused Ultrasound in ASD
A Phase 1 study testing Active LIFU in people with Autism Spectrum Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Active LIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- MRI or LIFU contraindications
- Recent investigational drug/device use
- Neurological illness (e.g., epilepsy, TBI)
- Substance use disorder
- Sensory/motor impairments preventing task completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MUSC Brain Stimulation Offices
Charleston, South Carolina, 29407
Kevin Caulfield, PhD, 843-792-1006, caulfiel@musc.edu
About this study
Official title: Low Intensity Focused Ultrasound in Autism Spectrum Disorder
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Active LIFU
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active LIFUDevice
In this open label study, all participants will receive active LIFU
| Study group | Role | What they receive |
|---|---|---|
| Active LIFU | Experimental | Not described Receives: Device: Active LIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness Scale, Second Edition (SRS-2)
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study startJul 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), COBRE in Neurodevelopment and its Disorders (CNDD)
- Responsible party
- Principal investigator, Kevin Caulfield, Medical University of South Carolina
- Investigators
- Kevin Caulfield, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225322
- Sponsor's protocol ID
- Pro00146822
- Other IDs
- 5P20GM148302
- Status last verified
- May 2026
- First submitted
- 4 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Focused Ultrasound in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07225322
- Acronym / sponsor ID
- Pro00146822
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), COBRE in Neurodevelopment and its Disorders (CNDD)
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active LIFU | Experimental | Device: Active LIFU |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 13-25
- Diagnosis of ASD (DSM-5)
- Full Scale IQ > 70
- Verbal communication
- Stable medication for ≥1 month
Key exclusion criteria (5 listed)
- MRI or LIFU contraindications
- Recent investigational drug/device use
- Neurological illness (e.g., epilepsy, TBI)
- Substance use disorder
- Sensory/motor impairments preventing task completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active LIFUIn this open label study, all participants will receive active LIFU | Device | Active LIFU |
Primary outcome
Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation; Visit 8, within 1 month of last stimulation)
3 secondary outcomes
Penn Emotion Identification Task
Time frame: 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
Time frame: 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)
Time frame: Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Caulfield, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Active LIFU in people with Autism Spectrum Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Caulfield, PhD (843-792-1006, caulfiel@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Responsiveness Scale, Second Edition (SRS-2) (time frame: Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation; Visit 8, within 1 month of last stimulation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.