Low Intensity Focused Ultrasound for Post-Traumatic Stress Disorder

Overseen By Adrienne Taren, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laureate Institute for Brain Research, Inc.

Must not be taking: Anxiolytics, Antipsychotics, Antidepressants, others

Disqualifiers: Neurological disorders, Psychotic disorders, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist frontline healthcare workers with post-traumatic stress disorder (PTSD). It uses low-intensity focused ultrasound (LIFU) to determine if it can alter brain activity patterns that may cause PTSD symptoms. Participants will receive either the ultrasound treatment or a sham version for comparison. This trial suits healthcare workers experiencing PTSD symptoms. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new PTSD treatments.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you've changed the dose or prescription of certain medications like antidepressants or mood stabilizers in the 6 weeks before enrolling.

What prior data suggests that this low-intensity focused ultrasound is safe for treating PTSD?

Research has shown that low-intensity focused ultrasound (LIFU) is generally safe for people. Past studies found no serious side effects or brain injuries, which is encouraging for potential trial participants. LIFU is a non-invasive method, meaning it doesn't involve surgery. Studies have explored its use for conditions like anxiety and depression, with positive safety results so far. While researchers continue to study the safety of LIFU, early findings suggest it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Low-intensity Focused Ultrasound (LIFU) is unique because it offers a non-invasive approach to treating Post-Traumatic Stress Disorder (PTSD), unlike traditional options like psychotherapy or medications such as SSRIs and SNRIs. Researchers are excited about LIFU because it specifically targets the ventral anterior cingulate cortex, a brain region involved in emotional regulation, offering a novel mechanism of action. This precise targeting could lead to fewer side effects and quicker results compared to standard treatments, potentially transforming how PTSD is managed.

What evidence suggests that low-intensity focused ultrasound is effective for post-traumatic stress disorder?

This trial will compare the effects of low-intensity focused ultrasound (LIFU) with a sham treatment for post-traumatic stress disorder (PTSD). Research has shown that LIFU could influence brain activity. As a non-invasive technique, it doesn't require surgery and can reach deep brain areas like the ventral anterior cingulate cortex (vACC), which helps regulate emotions. Early results suggest LIFU might reduce post-traumatic stress symptoms by affecting this brain area and its connection to the amygdala, a part of the brain involved in stress and fear. Initial studies in other conditions have demonstrated that LIFU can change brain activity, indicating potential usefulness for treating PTSD. However, more research is needed to confirm its effects specifically for PTSD. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for frontline healthcare workers who are experiencing post-traumatic stress disorder (PTSD). Participants must be willing to undergo brain scans and receive either LIFU or sham treatment. Specific eligibility criteria details were not provided.

Inclusion Criteria

English proficiency as evaluated by language ability during screening

PTSD Checklist for DSM-5 (PCL-5) score ≥ 33 and < 65

I work in a frontline healthcare position.

Exclusion Criteria

DSM-5 diagnosis of psychotic disorders, eating disorder, obsessive-compulsive disorder, moderate to severe alcohol or substance use disorder within the past year, bipolar disorder, or major depressive disorder with psychosis

Suicidal intent or plan (as measured by Suicide-Risk-Assessment-C-SSRS 'Yes' answers to items 3, 4 or 5 of Suicidal Ideation-Past 1 month section, or any 'Yes' answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months

History of severe traumatic brain injury (as indicated by score ≥ 3 on the Tulsa Head Injury Screen) or of skull fractures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete an initial fMRI session and baseline assessments

1 day

1 visit (in-person)

Treatment

Participants receive a single session of LIFU or sham modulation of the vACC

1 day

1 visit (in-person)

Post-Treatment Assessment

Participants complete a follow-up fMRI session and assessments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in PTSD symptoms and physiological metrics

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low-intensity Focused Ultrasound (LIFU)
• Sham Modulation

Trial Overview The study tests if low-intensity focused ultrasound (LIFU) on a part of the brain called the vACC can change its activity, connectivity, and reduce PTSD symptoms compared to a fake (sham) treatment.

How Is the Trial Designed?

Group I: Low intensity focused ultrasound (LIFU) Experimental Treatment 1 Intervention

LIFU of the ventral anterior cingulate cortex

Group II: Sham Placebo Group 1 Intervention

Sham neuromodulation (Sorbothane membrane over ultrasound probe)

Who Is Running the Clinical Trial?

Laureate Institute for Brain Research, Inc.

Lead Sponsor

Trials

53

Recruited

5,400+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10209047

Low intensity focused ultrasound - NIH RePORTER This application proposes the critical first-in-human research to develop a new kind of intervention, called low intensity focused ultrasound, for people ...

2. nature.com nature.com/articles/s41380-025-03033-w

Low-intensity transcranial focused ultrasound amygdala ... tFUS is a non-invasive technique for direct subcortical neuromodulation, but its safety, feasibility, and promise as a potential treatment is largely unknown.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1053811925004446

Low-intensity transcranial ultrasound stimulation promotes ... Specifically, fear conditioning often results in rapid and long-lasting spine elimination in the prefrontal cortex(Trouche et al., 2013; Davis ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07099950

Dose-Dependent Effects of Low-Intensity Focused ... Low-intensity focused ultrasound (LIFU) has emerged as a tool to modulate the activity of deep brain structures noninvasively and reversibly, ...

5. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(24)00192-X/fulltext

Low-intensity focused ultrasound (LIFU) for the treatment of ... Low-intensity focused ultrasound (LIFU) for the treatment of post-traumatic headache (PTH) in veterans: A feasibility study

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07164105

LIFU Mechanisms for PTSD in Healthcare Workers The goal of this clinical trial is to evaluate whether low-intensity focused ultrasound (LIFU) of the ventral anterior cingulate cortex (vACC) can normalize ...

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.825802/full

Low Intensity Focused Ultrasound for Non-invasive and ... The above studies provide preliminary evidence of safety, as no serious adverse events or brain injury were described. Most of these human ...

8. fusfoundation.org fusfoundation.org/posts/clinical-trial-investigates-low-intensity-focused-ultrasound-for-depression/

Clinical Trial Investigates Low-Intensity ... A clinical trial is investigating the safety and feasibility of using low-intensity focused ultrasound to address anxiety and depression.