Posttraumatic Stress DisorderPhase 2PTSD FUSNCT06820138
Focused Ultrasound for PTSD in Veterans
A Phase 2 study testing Brainsonix Ultrasound Device in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goal of this study is to develop a new, non-invasive brain stimulation modality called low intensity focused ultrasound (FUS) as a psychiatric rehabilitation treatment for posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Brainsonix Ultrasound Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2026to 29 Mar 2030
- Phase
- Phase 2
- 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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Veterans ages who meet DSM-5 criteria for chronic Post-traumatic stress disorder (PTSD) using the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and currently symptomatic. If applicable, Veterans will be required to be on stable psychiatric treatment(s) prior to baseline assessments
Who cannot join
- contraindications to focused ultrasound and/or neuroimaging:
- i) history of seizure disorder or serious neurologic illness including dementia or serious cognitive impairment,
- ii) structural or neurologic abnormalities present or in close proximity to sonication site
- iii) prior brain surgery
- iv) pacemaker or implanted central nervous system device
- v) greater than mild traumatic brain injury, or any head injury within sixty days of ultrasound
Show all 12Show fewer
- vi) greater than moderate alcohol or substance use disorders or active use or withdrawal from alcohol or substances
- vii) metal in the head
- viii) physical impediment likely to interfere with assessments, or
- ix) unable to follow protocols
- x) Veterans with significant white matter findings or those with findings in the beam of the ultrasound may also be excluded at discretion of study staff
- Veterans with acute suicidality are also excluded
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, 1 recruiting
- Recruiting
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
Kate J Barnabe, MHA, (401) 273-7100 ext. 16272, Kate.Barnabe@va.gov
Amy Mochel, Amy.Mochel@va.gov
About this study
Official title: Low Intensity Focused Ultrasound for Posttraumatic Stress Disorder
The goal of this study is to develop a new, non-invasive brain stimulation modality called low intensity focused ultrasound (FUS) as a psychiatric rehabilitation treatment for posttraumatic stress disorder (PTSD). FUS delivers energy comparable to that involved in diagnostic ultrasound but in a millimeter-sized envelope. Unlike currently available methods, the maximal FUS energy is delivered at a distance from a transducer on the scalp. Therefore, its promise is that it can deliver focal and reversible modulation to deeper brain regions involved in PTSD. The investigator team has previously conducted first-in-human research in FUS, and this study builds upon that work to conduct a phase II, dose-finding study. This study will pursue two Aims; the first is whether FUS to the amygdala can improve symptoms, and the second will evaluate whether FUS improves function by reduced disability, over a 1-month period. Short and longer-term effects of FUS will be measured and all FUS parameters are within FDA-defined safety thresholds for diagnostic ultrasound.
Read the detailed description
PTSD is highly prevalent in Veterans and is associated with significant psychiatric and medical comorbidity and healthcare utilization. Most importantly, PTSD prevents Veterans from reintegrating into society and is associated with significant disability and psychosocial dysfunction. Despite its prevalence and devastating impact, even the most efficacious treatments have modest success in improving either symptoms or functioning in Veterans with PTSD. One reason for this limited efficacy is the inability for current treatments to directly target and engage deep brain regions which are directly involved in PTSD psychopathology. However, recent advances in the areas of neuroscience, psychiatry and technology allow, for the first time, development of new technologies that can non-invasively and reversibly modulate deep brain structures through the use of low intensity focused ultrasound (FUS). This application is targeting the amygdala, which is a core region involved in PTSD and many other psychiatric disorders.
To date, cleared uses of focused ultrasound are high-intensity sonication to irreversibly ablate tissue, therapeutically for movement disorders and cancer-related pain. Effects are highly focal (i.e., millimeter-scale), and occur without adjacent tissue damage. In contrast, FUS as it is proposed here uses acoustic energy at the same precision but within safety limits for diagnostic ultrasound. Although therapeutic use of FUS remains largely unexplored, several groups demonstrated that FUS can safely modulates neural activity in mice, rabbit, swine, and non-human primates. Even more recent data indicates FUS can safely modulate human cortical activity, including that of somatosensory and motor cortex as well as the thalamus in healthy individuals.
Our group has been leading the effort to evaluate the use of FUS, by delivering a single dose of FUS inside the bore of an MRI scanner to a group of depressed Veterans. However, FUS has not yet been developed for PTSD, and before rigorous clinical trials of FUS for PTSD can be initiated, several key questions remain and are the focus of this study.
Using a phase II-style proof of concept/dose-finding study, investigators will characterize the effects of sham-controlled FUS administrations. Veterans with chronic PTSD first receive an MRI scan to facilitate high-precision targeting using out-of-scanner stereotactic neuronavigation. After targeting, Veterans are randomized to receive sham FUS, or one, two, or three FUS administrations per week over a month, and then Veterans will be followed for up to three months to evaluate longer-term effects. Neuroimaging MRI will be obtained prior to and following completion of FUS to explore neural effects. Thus, this study will evaluate the short-term durability of any effects on symptoms and function, and the design will provide important insight into the potential use for repeated administrations over time. The significance of this project lies in the potential to develop non-invasive deep brain stimulation for PTSD, with lessons learned that will be applicable for broader implementation; this goal can be realized through this careful and programmatic phase II study.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Brainsonix Ultrasound Device
- Keywords
- Low intensity focused ultrasound
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainsonix Ultrasound DeviceDevice
Also called Brainsonix Pulsar
This device delivers low intensity focused ultrasound and delivers either active or sham sonication depending upon the transducer pad used.
| Study group | Role | What they receive |
|---|---|---|
| Verum low intensity focused ultrasound | Active comparator | Verum (active) low intensity focused ultrasound, applied up to three times per week. Receives: Device: Brainsonix Ultrasound Device |
| Sham low intensity focused ultrasound | Sham comparator | Sham (inactive) low intensity focused ultrasound, applied up to three times per week. Receives: Device: Brainsonix Ultrasound Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic stress disorder (PTSD) Checklist for DSM5
The PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5) is a gold standard self reported scale of PTSD symptoms. Scores range from 0-80, where higher scores indicate greater symptom severity. The Week 5 visit value is the primary outcome measure of the study.
Measured: Up to 3 months
Secondary outcomes (5)
Sheehan Disability Scale
The Sheehan Disability Scale (SDS) is a self report tool used to assess functional impairment in work, social and family life. Scores range from 0-30, where higher scores indicate greater impairment.
Measured: Up to 3 months
Social and Occupational Function Scale
The Social and Occupational Function Scale (SOFAS) assesses social and occupational function, and is scored from 0-100, where higher scores indicate superior (better) social and occupational function.
Measured: Up to 3 months
Inventory of Depressive Symptoms Self Report
The Inventory of Depressive Symptoms, Self-Report (IDSSR) is a rating scale that measures self-reported depressive symptoms. Scores range from 0-84, where higher scores indicate more severe depressive symptom severity.
Measured: Up to 3 months
Clinician Administered PTSD Scale
The Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual-5 (CAPS-5) is structured clinical interview for posttraumatic stress disorder symptoms. Scores range from 0-80, where higher symptoms indicate more severe symptom severity.
Measured: Up to 3 months
Clinician Global Impression
The Clinician Global Impression scale assesses a clinician's general impression of severity. Scores typically range from 1 (not at all ill) to 7 (very ill); Improvement scores range from 1 (very much improved) to 7 (very much worse).
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start9 Sep 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion29 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind delivery of low intensity focused ultrasound (i.e., active low intensity focused ultrasound versus a sham (placebo) administration of low intensity focused ultrasound). Sessions are approximately three times a week for four weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Noah S. Philip, MD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820138
- Sponsor's protocol ID
- N5299-R
- Acronym
- PTSD FUS
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Focused Ultrasound for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06820138
- Acronym / sponsor ID
- PTSD FUS / N5299-R
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Low intensity focused ultrasound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 29 Mar 2030 (estimated)
- First posted
- 11 Feb 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.
The goal of this study is to develop a new, non-invasive brain stimulation modality called low intensity focused ultrasound (FUS) as a psychiatric rehabilitation treatment for posttraumatic stress disorder (PTSD). FUS delivers energy comparable to that involved in diagnostic ultrasound but in a millimeter-sized envelope. Unlike currently available methods, the maximal FUS energy is delivered at a distance from a transducer on the scalp. Therefore, its promise is that it can deliver focal and reversible modulation to deeper brain regions involved in PTSD. The investigator team has previously conducted first-in-human research in FUS, and this study builds upon that work to conduct a phase II, dose-finding study. This study will pursue two Aims; the first is whether FUS to the amygdala can improve symptoms, and the second will evaluate whether FUS improves function by reduced disability, over a 1-month period. Short and longer-term effects of FUS will be measured and all FUS parameters are within FDA-defined safety thresholds for diagnostic ultrasound.
Detailed description
PTSD is highly prevalent in Veterans and is associated with significant psychiatric and medical comorbidity and healthcare utilization. Most importantly, PTSD prevents Veterans from reintegrating into society and is associated with significant disability and psychosocial dysfunction. Despite its prevalence and devastating impact, even the most efficacious treatments have modest success in improving either symptoms or functioning in Veterans with PTSD. One reason for this limited efficacy is the inability for current treatments to directly target and engage deep brain regions which are directly involved in PTSD psychopathology. However, recent advances in the areas of neuroscience, psychiatry and technology allow, for the first time, development of new technologies that can non-invasively and reversibly modulate deep brain structures through the use of low intensity focused ultrasound (FUS). This application is targeting the amygdala, which is a core region involved in PTSD and many other psychiatric disorders.
To date, cleared uses of focused ultrasound are high-intensity sonication to irreversibly ablate tissue, therapeutically for movement disorders and cancer-related pain. Effects are highly focal (i.e., millimeter-scale), and occur without adjacent tissue damage. In contrast, FUS as it is proposed here uses acoustic energy at the same precision but within safety limits for diagnostic ultrasound. Although therapeutic use of FUS remains largely unexplored, several groups demonstrated that FUS can safely modulates neural activity in mice, rabbit, swine, and non-human primates. Even more recent data indicates FUS can safely modulate human cortical activity, including that of somatosensory and motor cortex as well as the thalamus in healthy individuals.
Our group has been leading the effort to evaluate the use of FUS, by delivering a single dose of FUS inside the bore of an MRI scanner to a group of depressed Veterans. However, FUS has not yet been developed for PTSD, and before rigorous clinical trials of FUS for PTSD can be initiated, several key questions remain and are the focus of this study.
Using a phase II-style proof of concept/dose-finding study, investigators will characterize the effects of sham-controlled FUS administrations. Veterans with chronic PTSD first receive an MRI scan to facilitate high-precision targeting using out-of-scanner stereotactic neuronavigation. After targeting, Veterans are randomized to receive sham FUS, or one, two, or three FUS administrations per week over a month, and then Veterans will be followed for up to three months to evaluate longer-term effects. Neuroimaging MRI will be obtained prior to and following completion of FUS to explore neural effects. Thus, this study will evaluate the short-term durability of any effects on symptoms and function, and the design will provide important insight into the potential use for repeated administrations over time. The significance of this project lies in the potential to develop non-invasive deep brain stimulation for PTSD, with lessons learned that will be applicable for broader implementation; this goal can be realized through this careful and programmatic phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind delivery of low intensity focused ultrasound (i.e., active low intensity focused ultrasound versus a sham (placebo) administration of low intensity focused ultrasound). Sessions are approximately three times a week for four weeks.
| Arm | Type | Receives |
|---|---|---|
| Verum low intensity focused ultrasound | Active comparator | Device: Brainsonix Ultrasound DeviceVerum (active) low intensity focused ultrasound, applied up to three times per week. |
| Sham low intensity focused ultrasound | Sham comparator | Device: Brainsonix Ultrasound DeviceSham (inactive) low intensity focused ultrasound, applied up to three times per week. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Veterans ages who meet DSM-5 criteria for chronic Post-traumatic stress disorder (PTSD) using the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and currently symptomatic. If applicable, Veterans will be required to be on stable psychiatric treatment(s) prior to baseline assessments
Key exclusion criteria (12 listed)
- contraindications to focused ultrasound and/or neuroimaging:
- Veterans with acute suicidality are also excluded
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 |
|---|---|---|
| Brainsonix Ultrasound DeviceAlso: Brainsonix PulsarThis device delivers low intensity focused ultrasound and delivers either active or sham sonication depending upon the transducer pad used. | Device | Sham low intensity focused ultrasound, Verum low intensity focused ultrasound |
Primary outcome
Post-traumatic stress disorder (PTSD) Checklist for DSM5
Time frame: Up to 3 months
The PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5) is a gold standard self reported scale of PTSD symptoms. Scores range from 0-80, where higher scores indicate greater symptom severity. The Week 5 visit value is the primary outcome measure of the study.
5 secondary outcomes
Sheehan Disability Scale
Time frame: Up to 3 months
Social and Occupational Function Scale
Time frame: Up to 3 months
Inventory of Depressive Symptoms Self Report
Time frame: Up to 3 months
Clinician Administered PTSD Scale
Time frame: Up to 3 months
Clinician Global Impression
Time frame: Up to 3 months
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Noah S. Philip, MD principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brainsonix Ultrasound Device in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development 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 1 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 15 Sep 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Noah S Philip, MD ((401) 273-7100 ext. 14328, noah.philip@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic stress disorder (PTSD) Checklist for DSM5 (time frame: Up to 3 months). 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 15 Sep 2026.