Ultrasound Therapy for PTSD

Overseen By Elisabeth Wilde, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Utah

Disqualifiers: Inability to complete MRI, Suicidal ideation

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new brain therapy for individuals with post-traumatic stress disorder (PTSD). The therapy uses ultrasound waves to gently stimulate brain areas affected by PTSD, aiming to improve symptoms such as mood and memory. Known as Diadem (or Low-Intensity Transcranial Focused Ultrasound Stimulation, also called Ultrasonic Neuromodulation), this treatment will be administered to participants. Participants will receive either the actual treatment or a sham (fake) version to compare results. Ideal candidates have a confirmed PTSD diagnosis and noticeable symptoms. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ultrasound therapy is safe for individuals with PTSD?

Research shows that low-intensity transcranial focused ultrasound stimulation, such as the Diadem treatment, is generally well-tolerated. Studies have found it can safely reach deep brain areas to help with mood, anxiety, and trauma-related issues. Some clinical trials report that this type of ultrasound therapy is both effective and safe for people with treatment-resistant depression. However, other research indicates that the overall safety and practicality remain unclear. More studies are needed to confirm these results. As this trial is in its early stages, researchers will closely monitor both safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for PTSD?

Unlike the standard PTSD treatments, which often involve medications like antidepressants or therapies such as cognitive behavioral therapy, Diadem uses a novel approach with low-intensity transcranial focused ultrasound. This method targets deep brain areas affected by PTSD, potentially offering more direct and rapid relief. Researchers are excited because this technique could minimize side effects typically associated with drugs and might provide quicker results than traditional therapies. Additionally, the use of ultrasound represents a non-invasive option, which is a significant advantage over more intrusive treatments.

What evidence suggests that this ultrasound therapy is effective for PTSD?

Research has shown that low-intensity transcranial focused ultrasound stimulation (tFUS), which participants in this trial may receive as part of the active stimulation arm, might help treat mood, anxiety, and trauma-related disorders. One study demonstrated that tFUS improved symptoms in these areas, offering hope for people with PTSD. This method works by safely targeting deep parts of the brain connected to PTSD, aiming to change brain activity. Although researchers are still learning about the safety and long-term effects of tFUS, early results are promising. These findings suggest that tFUS could be a helpful new way to manage PTSD symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Jan Kubanek, PhD

Principal Investigator

University of Utah

Elisabeth Wilde, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for individuals with a confirmed diagnosis of PTSD, indicated by a score greater than 20 on the PCL-5 assessment. It's not suitable for those who don't meet this specific diagnostic threshold.

Inclusion Criteria

You have been diagnosed with PTSD and your PCL-5 score is higher than 20.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Stimulation and Monitoring

Low-intensity transcranial focused ultrasound stimulation delivered with various parameters during psychophysical and physiological monitoring

4 weeks

Multiple visits for stimulation and monitoring

Blinded Randomized Sham-Controlled Cross-Over Trial

Testing of a well-tolerated stimulation protocol in a blinded randomized sham-controlled cross-over trial

8 weeks

Regular visits for treatment and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diadem

Trial Overview

The study is testing 'Diadem', which uses low-intensity focused ultrasound to stimulate the brain non-invasively in people with PTSD. The effectiveness will be measured through MRI scans and assessments of PTSD severity, cognitive function, and mood changes.

How Is the Trial Designed?

Group I: Active stimulation Experimental Treatment 1 Intervention

Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by PTSD.

Group II: Sham stimulation Placebo Group 1 Intervention

Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Focal brain stimulation shows promise as a treatment for PTSD, with evidence suggesting that targeting specific brain areas involved in fear response and emotion regulation can enhance treatment efficacy.

Current research indicates that downregulating fear-related circuits (like the amygdala) and upregulating emotion regulation areas (like the prefrontal cortex) may be key to improving PTSD treatment outcomes, but more studies are needed to validate these targets and explore additional ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining focal brain stimulation targets for PTSD using neuroimaging. van Rooij, SJH., Sippel, LM., McDonald, WM., et al.[2022]

Posttraumatic stress disorder (PTSD) symptoms arise from dysregulation of the fear system, which can be studied in animals through Pavlovian fear conditioning to understand the neurobiology behind these responses.

The review highlights both established and emerging treatments for PTSD, including pharmacotherapies and device-based interventions, developed through a translational model that bridges laboratory research to clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Overview of Translationally Informed Treatments for Posttraumatic Stress Disorder: Animal Models of Pavlovian Fear Conditioning to Human Clinical Trials. Bowers, ME., Ressler, KJ.[2021]

Electroconvulsive therapy has shown success in treating some individuals with PTSD who have not responded to other treatments, although reports on its effectiveness are limited.

New neuromodulation strategies, such as repetitive transcranial magnetic stimulation and vagus nerve stimulation, are being explored as experimental treatments for PTSD, indicating a growing interest in alternative therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulatory treatments for post-traumatic stress disorder (PTSD). Koek, RJ., Roach, J., Athanasiou, N., et al.[2019]

In a study involving 30 rats, 40 Hz acousto-optical stimulation significantly reduced anxiety-like symptoms associated with PTSD, as evidenced by improved behavior in tests like the elevated plus maze and open field test after 7 days of stimulation.

The mechanism behind this improvement appears to be linked to increased levels of brain-derived neurotrophic factor (BDNF) and its receptor TrkB, suggesting that the stimulation enhances synaptic plasticity in the brain regions involved in anxiety regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of 40 Hz multisensory stimulation on trauma-induced anxiety-like behavior in rats]. Yin, JY., Gao, XJ., Zhang, XY., et al.[2023]

The study involved 12 Veterans with PTSD who underwent six sessions of virtual reality exposure combined with transcranial direct current stimulation (tDCS), targeting the ventromedial prefrontal cortex, showing that this combination can be applied without technical issues.

Results indicated that the tDCS combined with VR significantly reduced physiological arousal and led to a clinically meaningful decrease in PTSD symptoms, suggesting potential for this approach in future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined transcranial direct current stimulation with virtual reality exposure for posttraumatic stress disorder: Feasibility and pilot results. van 't Wout-Frank, M., Shea, MT., Larson, VC., et al.[2021]

Recent studies indicate that drugs with serotonergic actions can provide significant symptom relief for PTSD patients over an 8-week treatment period, enhancing their ability to engage in therapy.

Controlled and double-blind trials have shown positive outcomes, suggesting that pharmacotherapy can be an effective component of a comprehensive treatment plan for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic stress disorder. Vargas, MA., Davidson, J.[2007]

Posttraumatic stress disorder (PTSD) affects 1-9% of the general population, but its prevalence can rise to 19-70% among those who have experienced traumatic events, indicating a significant impact on affected individuals.

Selective serotonin reuptake inhibitors (SSRIs) have been shown to be effective in treating PTSD, with studies demonstrating significant improvements in both civilian and veteran populations, and no gender-related differences in clinical response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Posttraumatic stress disorder (PTSD)]. Martényi, F.[2022]

Citations

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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.

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fusfoundation.org

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

Clinical Trial Results

Clinical Trial Results: Focused Ultrasound Neuromodulation Improves Mood, Anxiety, and Trauma-Related Disorders. Published: September 19, 2025.

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sciencedirect.com

sciencedirect.com/science/article/pii/S1053811925004446

Low-intensity transcranial ultrasound stimulation promotes ...

Treating post-traumatic stress disorder with neuromodulation therapies: transcranial magnetic stimulation, transcranial direct current ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40275098/

a double-blind sham-controlled target engagement study and ...

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

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06135064/ultrasonic-neuromodulation-for-treatment-of-ptsd?page=2&id=122&slug=post-traumatic-stress-disorders

Ultrasonic Neuromodulation for Treatment of PTSD

This study will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (PTSD).

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04306601

NCT04306601 | Low-Intensity Focused Ultrasound on ...

Improved the consciousness after DBS have been reported , but the evidence isn't still sufficient and the risk is too high to be administered to patients with ...

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fusfoundation.org

fusfoundation.org/posts/spire-deploys-effective-safe-ultrasonic-neuromodulation-device/

SPIRE Deploys Effective, Safe Ultrasonic ...

Results from two Phase 2 clinical trials support its effective and safe deployment in patients with treatment-resistant depression and ...