Focused Ultrasound for Post-Traumatic Stress Disorder

(PTSD FUS Trial)

Overseen By Alison Gorbatov

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Disqualifiers: Seizure disorder, Dementia, Brain surgery, Alcohol use, Suicidality, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new brain treatment called focused ultrasound to determine its effectiveness for people with PTSD, a condition that can develop after traumatic events. The treatment targets deep brain areas linked to PTSD symptoms to improve daily functioning. Participants are divided into two groups: one receives the actual ultrasound treatment, while the other receives a placebo version for comparison. Veterans with ongoing PTSD symptoms who are on stable psychiatric treatment might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in PTSD treatment.

Will I have to stop taking my current medications?

The trial requires that veterans be on stable psychiatric treatments before starting the study, so you may not need to stop your current medications. However, the protocol does not specify any changes to existing medications.

What prior data suggests that this focused ultrasound technique is safe for treating PTSD?

A previous study found focused ultrasound (FUS) for PTSD to be safe, meeting the FDA standards for regular ultrasound scans. It uses energy levels similar to those in common ultrasound tests. Research has shown that FUS is non-invasive, eliminating concerns about surgical cuts or infections. In past trials, researchers monitored side effects and found them minimal, suggesting that patients tolerate FUS well. Since FUS is already widely used for other conditions, such as uterine fibroids, it has a strong safety record in many cases. ^{1 2 3 4 5}

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

Researchers are excited about focused ultrasound for treating PTSD because it offers a non-invasive alternative to traditional therapies like medications and psychotherapy. Unlike drugs that may take weeks to work and can have side effects, focused ultrasound uses sound waves to target specific brain areas, potentially providing faster relief with fewer side effects. The treatment is applied externally, without the need for surgery, making it a promising option for patients seeking less invasive solutions. This new approach could revolutionize how we manage PTSD, offering hope for quicker and more precise treatment outcomes.

What evidence suggests that focused ultrasound is effective for PTSD?

This trial will compare the effects of verum (active) low-intensity focused ultrasound with a sham (inactive) version for treating PTSD. Studies have shown that focused ultrasound can effectively help people with PTSD. In one study, patients experienced a significant reduction in anxiety and mood-related symptoms. This treatment targets the amygdala, a part of the brain that manages emotions, by sending focused energy to improve its function without surgery. Initial findings suggest that focused ultrasound is safe and can lead to improvements in PTSD symptoms. This non-invasive approach shows promise for those seeking new treatment options. ^{1 2 3 5 6}

Who Is on the Research Team?

Noah S. Philip, MD

Principal Investigator

Providence VA Medical Center, Providence, RI

Are You a Good Fit for This Trial?

This trial is for veterans with PTSD. It's testing a new, non-invasive brain stimulation treatment using focused ultrasound (FUS). Participants should have PTSD symptoms that might be improved by targeting the amygdala in the brain. Details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am a veteran with stable psychiatric treatment before starting the study.

I am a veteran aged 22-70 with chronic PTSD diagnosed by a professional.

Exclusion Criteria

Greater than mild traumatic brain injury, or any head injury within sixty days of ultrasound

Veterans with acute suicidality are also excluded

I have had brain surgery before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Targeting and Randomization

Participants receive an MRI scan for high-precision targeting and are randomized to receive sham or active FUS

1 week

1 visit (in-person)

Treatment

Participants receive sham or active FUS administrations up to three times per week

4 weeks

Up to 12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Focused Ultrasound

Trial Overview The study is examining low intensity FUS as a potential psychiatric rehabilitation treatment for PTSD. The energy used is similar to diagnostic ultrasound but targets millimeter-sized areas deep within the brain, like the amygdala, to see if it can reduce symptoms and disability over one month.

How Is the Trial Designed?

Group I: Verum low intensity focused ultrasound Active Control 1 Intervention

Verum (active) low intensity focused ultrasound, applied up to three times per week.

Group II: Sham low intensity focused ultrasound Placebo Group 1 Intervention

Sham (inactive) low intensity focused ultrasound, applied up to three times per week.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a large retrospective analysis involving over 78,000 doses of ultrasound contrast agents (Definity and Optison), only 0.01% of patients experienced severe adverse reactions, indicating a strong safety profile for these agents.

The study found that severe reactions were primarily in outpatients, with no serious events reported in critically ill patients, suggesting that ultrasound contrast agents are safe for use in a variety of clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. Wei, K., Mulvagh, SL., Carson, L., et al.[2022]

In a phase 1 study involving 15 participants, intense ultrasound treatment for facial and neck tissues was found to be safe, with no significant adverse effects reported and only mild discomfort experienced by patients.

Histological analysis showed that the treatment created consistent thermal injury zones in the dermis without damaging the epidermis, indicating a targeted and effective approach for skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Gliklich, RE., White, WM., Slayton, MH., et al.[2012]

Focused ultrasound is a noninvasive brain stimulation technique that offers precise targeting, combining benefits from both repetitive transcranial magnetic stimulation and deep brain stimulation.

High-intensity focused ultrasound is already being used in incisionless surgeries, such as capsulotomies for treating obsessive-compulsive disorder, showcasing its therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound as a Neurotherapeutic: A Circuit- and System-Based Interrogation. Spivak, NM., Tyler, WJ., Bari, AA., et al.[2023]

Microfocused Ultrasound with Visualization (MFU-V) has a well-established safety profile, showing only mild and transient side effects like tenderness and redness, with rare adverse events typically linked to improper technique.

When used correctly, MFU-V treatments are safe, with most side effects resolving quickly and without lasting effects, indicating its efficacy in cosmetic dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. Hitchcock, TM., Dobke, MK.[2022]

Citations

1. fusfoundation.org fusfoundation.org/diseases-and-conditions/post-traumatic-stress-disorder/

Post-Traumatic Stress Disorder (PTSD) Learn about clinical trials that are investigating the use of focused ultrasound to treat Post-Traumatic Stress Disorder (PTSD)

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

Low-intensity transcranial focused ultrasound amygdala ... Most secondary outcomes demonstrated pre- to post-treatment improvements at p < 0.05 uncorrected (Supplementary Fig. 5 and Table 2), including ...

3. 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 ...

4. fusfoundation.org fusfoundation.org/posts/clinical-trial-results-focused-ultrasound-neuromodulation-improves-mood-anxiety-and-trauma-related-disorders/

Clinical Trial Results The primary outcome was met, and the treatment led to significant reductions in MASQ-GD scores (p = 0.001, Cohen's d = 0.77). Amygdala ...

5. withpower.com withpower.com/trial/phase-2-stress-disorders-traumatic-1-2026-3d765

Focused Ultrasound for Post-Traumatic Stress Disorder What data supports the effectiveness of the treatment Focused Ultrasound for Post-Traumatic Stress Disorder? Focused ultrasound is a promising noninvasive ...

6. fusfoundation.org fusfoundation.org/posts/focused-ultrasound-exceeds-one-million-patients-treated-worldwide/

Focused Ultrasound Exceeds One Million Patients Treated ... According to data from focused ultrasound manufacturers, uterine fibroids remain the most treated condition, with nearly 379,000 patients ...