Major Depressive EpisodePhase 1/2NCT05301036
Personalized Ultrasonic Brain Stimulation for Depression
A Phase 1/2 study testing Diadem prototype in people with Major Depressive Episode, run by University of Utah at 1 site in United States.
Trial summary
This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Diadem prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 14 Jul 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
- Age 18-65, any gender
- Primary diagnosis of major depressive disorder or bipolar disorder
- Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months
- Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score > 10
- Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study
- For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
- Capacity to provide informed consent; provision of a signed and dated consent form
Who cannot join
- History of serious brain injury or other neurologic disorder
- Poorly managed general medical condition
- Pregnant or breast feeding
- Implanted device in the head or neck
- MRI intolerance or contraindication
- Brain stimulation (e.g., ECT, TMS, VNS) in the past month
Show all 15Show fewer
- Suicidal ideation (Columbia Suicide Severity Rating Scale screen item #2, past month)
- Lifetime history of a serious suicide attempt
- Moderate-to-severe substance use disorder (past 3 months)
- Obsessive compulsive disorder (past month)
- Posttraumatic stress disorder (past month)
- Schizophrenia-spectrum disorder (lifetime)
- Neurocognitive disorder (past year)
- Personality disorder as a current focus of treatment
- Clinically inappropriate for participation in the study as determined by the study team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Ultrasonic Brain Stimulation for Depression: A Pilot Study of Target Engagement and Mood Effects
This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.
- Conditions
- Major Depressive Episode
- Being tested
- Diadem prototype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diadem prototypeDevice
Diadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Personalized low-intensity transcranial focused ultrasound stimulation of deep brain target (subgenual cingulate or alternative targets) Receives: Device: Diadem prototype |
| Sham stimulation | Sham comparator | Personalized low-intensity transcranial focused ultrasound stimulation of lateral ventricle Receives: Device: Diadem prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target engagement: MRI quantification of brain activation
Blood oxygenation level dependent (BOLD) or arterial spin labeling (ASL) response to active versus sham stimulation
Measured: 1 day at MRI study visit
Target engagement: MRI quantification of brain connectivity
Resting functional connectivity of target in response to active versus sham stimulation
Measured: 1 day at MRI study visit
Change in depression severity measured with the HDRS-6
6-item Hamilton Depression Rating Scale (HDRS-6), range 0-22, higher score represents greater depression
Measured: 1 day and 7 days after stimulation
Change in Sadness scale of PANAS-X
Positive and Negative Affect Schedule Extended (PANAS-X), range 0-100, higher score represents greater sadness
Measured: 1 hour, at stimulation study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Jul 2022
- Primary completion14 Jul 2024
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive EpisodeStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Mickey, University of Utah
- Investigators
- Brian J Mickey, MD, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301036
- Sponsor's protocol ID
- IRB_00148802
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riis TS, Feldman DA, Vonesh LC, Brown JR, Solzbacher D, Kubanek J, Mickey BJ. Durable effects of deep brain ultrasonic neuromodulation on major depression: a case report. J Med Case Rep. 2023 Oct 28;17(1):449. doi: 10.1186/s13256-023-04194-4.
PubMed 37891643
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Ultrasonic Brain Stimulation for Depression: A Pilot Study of Target Engagement and Mood Effects
- ClinicalTrials.gov ID
- NCT05301036
- Acronym / sponsor ID
- IRB_00148802
- Conditions
- Major Depressive Episode
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 29 Mar 2022 (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 brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.
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: Diadem prototypePersonalized low-intensity transcranial focused ultrasound stimulation of deep brain target (subgenual cingulate or alternative targets) |
| Sham stimulation | Sham comparator | Device: Diadem prototypePersonalized low-intensity transcranial focused ultrasound stimulation of lateral ventricle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-65, any gender
- Primary diagnosis of major depressive disorder or bipolar disorder
- Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months
- Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score > 10
- Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study
Key exclusion criteria (15 listed)
- History of serious brain injury or other neurologic disorder
- Poorly managed general medical condition
- Pregnant or breast feeding
- Implanted device in the head or neck
- MRI intolerance or contraindication
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 |
|---|---|---|
| Diadem prototypeDiadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation | Device | Active stimulation, Sham stimulation |
Primary outcome
Target engagement: MRI quantification of brain activation
Time frame: 1 day at MRI study visit
Blood oxygenation level dependent (BOLD) or arterial spin labeling (ASL) response to active versus sham stimulation
Target engagement: MRI quantification of brain connectivity
Time frame: 1 day at MRI study visit
Resting functional connectivity of target in response to active versus sham stimulation
Change in depression severity measured with the HDRS-6
Time frame: 1 day and 7 days after stimulation
6-item Hamilton Depression Rating Scale (HDRS-6), range 0-22, higher score represents greater depression
Change in Sadness scale of PANAS-X
Time frame: 1 hour, at stimulation study visit
Positive and Negative Affect Schedule Extended (PANAS-X), range 0-100, higher score represents greater sadness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 37891643Riis TS, Feldman DA, Vonesh LC, Brown JR, Solzbacher D, Kubanek J, Mickey BJ. Durable effects of deep brain ultrasonic neuromodulation on major depression: a case report. J Med Case Rep. 2023 Oct 28;17(1):449. doi: 10.1186/s13256-023-04194-4.
- 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.
Brian J Mickey, MD, PhD principal investigator
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 prototype in people with Major Depressive Episode, 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 9 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Target engagement: MRI quantification of brain activation (time frame: 1 day at MRI study visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301036, which also lists 1 linked publication.
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 9 Sep 2026.