PTSDPhase 1/2NCT06135064
Ultrasonic Neuromodulation for Treatment of PTSD
A Phase 1/2 study testing Diadem in people with PTSD, run by University of Utah at 1 site in United States.
Trial summary
This study will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (PTSD). Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- Diadem
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to 27 Sep 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive PTSD diagnosis; PCL-5 > 20
Who cannot join
- Inability to complete MRI
- Suicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Post-traumatic Stress Disorder
This study will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (PTSD). Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and numerical scales of PTSD, cognitive performance, and mood.
- Conditions
- PTSD
- Being tested
- Diadem
- 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.
DiademDevice
The device delivers low-intensity ultrasonic waves into specified brain targets.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by PTSD. Receives: Device: Diadem |
| Sham stimulation | Sham comparator | Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses. Receives: Device: Diadem |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The total severity scores range from 0 to 80.
Measured: Up to 3 months following study initiation
Secondary outcomes (5)
National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB)
The NIHTB-CB provides the following summary scores: Total Cognition Composite, Fluid Composite (includes Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory (Form A), List Sorting Working Memory, and Pattern Comparison tests), and Crystallized Composite (includes Picture Vocabulary and Oral Reading Recognition tests). The scores are normalized to have a mean score of 10 and standard deviation of 3.
Measured: Up to 3 months following study initiation
California Verbal Learning Test, 3rd Edition (CVLT3)
A verbal learning and memory test designed to test immediate recall, short delay recall, long delay recall, and recognition memory, as well as the memory strategies being used by the participant. The Brief Form of the CVLT 3 consists of nine words, administered repeatedly over 4 immediate recall trials. The scoring software provides normative data.
Measured: Up to 3 months following study initiation
PROMIS scale of Pain Intensity
The score assess the worst, average, and current levels of pain on a scale from 1 (no pain) to 5 (very severe)
Measured: Up to 3 months following study initiation
Hamilton Depression Rating Scale (HDRS-17)
This 17-item questionnaire rates the severity of depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The scores range from 0 (no symptoms) to 52 (worst possible).
Measured: Up to 3 months following study initiation
Pittsburgh Sleep Quality Index (PSQI)
Test consisting of 7 components summed to yield a global PSQI score, ranging from of 0 (good sleep) to 21 (poor sleep).
Measured: Up to 3 months following study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start5 Apr 2024
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Why it stopped: IRB administrative closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Kubanek, University of Utah
- Investigators
- Jan Kubanek, PhD, Principal investigator, University of UtahElisabeth Wilde, PhD, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135064
- Sponsor's protocol ID
- IRB_00173062
- Status last verified
- Apr 2025
- First submitted
- 8 Nov 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06135064
- Acronym / sponsor ID
- IRB_00173062
- Conditions
- PTSD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB administrative closure
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 18 Nov 2023 (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 will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (PTSD). Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and numerical scales of PTSD, cognitive performance, and mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: DiademLow-intensity transcranial focused ultrasound stimulation of deep brain targets affected by PTSD. |
| Sham stimulation | Sham comparator | Device: DiademSham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive PTSD diagnosis; PCL-5 > 20
Key exclusion criteria (2 listed)
- Inability to complete MRI
- Suicidal ideation
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 |
|---|---|---|
| DiademThe device delivers low-intensity ultrasonic waves into specified brain targets. | Device | Active stimulation, Sham stimulation |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Up to 3 months following study initiation
20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The total severity scores range from 0 to 80.
5 secondary outcomes
National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB)
Time frame: Up to 3 months following study initiation
California Verbal Learning Test, 3rd Edition (CVLT3)
Time frame: Up to 3 months following study initiation
PROMIS scale of Pain Intensity
Time frame: Up to 3 months following study initiation
Hamilton Depression Rating Scale (HDRS-17)
Time frame: Up to 3 months following study initiation
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Up to 3 months following study initiation
Results and safety
The study was stopped early (reason given: IRB administrative closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- 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. This study is not recruiting at the moment.
Jan Kubanek, PhD principal investigator
University of Utah
Elisabeth Wilde, PhD study chair
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Diadem in people with PTSD, run by University of Utah 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 2 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: stopped early, as of the sponsor's last update on 25 May 2025. 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 combined 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.
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?
The study was stopped early (reason given: IRB administrative closure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Up to 3 months following study initiation). 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 25 May 2025.