Suicidal IdeationNCT07923461
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
A study testing DIADEM Low-Intensity Focused Ultrasound Neuromodulation in people with Suicidal Ideation and Cognitive Control, run by University of Minnesota at 1 site in United States.
Trial summary
SERENE is an experimental study evaluating low-intensity focused ultrasound neuromodulation of cognitive control circuitry in adults with a lifetime history of suicide attempt or suicidal ideation, but without current suicidality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Ideation, Cognitive Control, Neurocognitive Function
- What is being tested?
- DIADEM Low-Intensity Focused Ultrasound Neuromodulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 20 Sep 2028
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lifetime history of suicide attempt or suicidal ideation, as determined by the Columbia-Suicide Severity Rating Scale
- Score in specified ranges on measures of cognitive control behavior and/or cognitive control circuit function
- No current suicide ideation or behavior within the past 3 months, as determined by the Columbia-Suicide Severity Rating Scale
- Age 18 to 65 years
- Speaks and understands English
- Primary user of a smartphone
Who cannot join
- Under age 18
- Neurological disorder that may affect fMRI scan results or cause reaction to LIFU to differ from healthy adults
- Regular use of psychoactive medication, except PRN use if the participant is willing and able to abstain during the study period
- Psychiatric hospitalization within the past 3 months
- Contraindication to fMRI scanning, including claustrophobia, unremovable piercings, pregnancy, medical devices such as pacemakers, or a movement or sleep disorder
- Pregnant or may have reason to believe they are pregnant
Show all 21Show fewer
- Diagnosis of certain psychiatric conditions, such as schizophrenia, bipolar disorder, or a developmental disorder other than ADHD
- Any other neurological, autoimmune, or medical disorder that may inhibit participation
- Children
- Pregnant women/persons
- Fetuses
- Neonates
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Non-English speakers
- Individuals unable to read
- Employees of the researcher
- Students of the researcher
- Individuals approached during a stressful situation, such as an emergency room setting or childbirth
- Individuals with fear of negative consequences for not participating
- Any other circumstance that could increase vulnerability to coercion or exploitation
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
Masonic Institute for the Developing Brain
Minneapolis, Minnesota, 55455
Michael V Bronstein, PhD, 781-492-5644, brons139@umn.edu
About this study
Official title: Suicide-related Experience Reduction Via Enhancement of Neuroplasticity
SERENE is an experimental study evaluating low-intensity focused ultrasound neuromodulation of cognitive control circuitry in adults with a lifetime history of suicide attempt or suicidal ideation, but without current suicidality.
Participants will complete screening, cognitive control tasks, MRI/fMRI, ecological momentary assessments, and low-intensity focused ultrasound neuromodulation using the DIADEM system. The study will examine whether low-intensity focused ultrasound (LIFU) neuromodulation changes cognitive control performance measured by the Multi-Source Interference Task (MSIT) and EEG event-related spectral power in the alpha and theta frequency bands.
The study will also examine the time course of LIFU effects and explore whether changes in cognitive control circuitry relate to self-reported experiences, including mood, anxiety, psychosis symptoms, suicidal ideation, and emotion regulation.
Read the detailed description
SERENE is an experimental study designed to test a personalized, non-invasive neuromodulation technique to investigate the neural basis of cognitive control.
The study will enroll adults with a lifetime history of suicide attempt or suicidal ideation, but without current suicidal ideation or behavior. Participants will be screened using the Columbia-Suicide Severity Rating Scale to confirm suicide history and exclude current suicidality. Participants will also complete MRI/fMRI-based cognitive control screening to identify cognitive control circuit function.
Participants will complete baseline cognitive and self-report assessments, including computerized cognitive tasks and clinical/self-report measures. Ecological momentary assessments will be completed before and after neuromodulation to assess symptoms and daily-life experiences related to cognitive control, including mood, anxiety, psychosis-related symptoms, suicidal ideation, and emotion regulation.
The study intervention is low-intensity focused ultrasound neuromodulation delivered using the DIADEM system. LIFU will be applied to deep brain regions involved in cognitive control, including subregions of the internal capsule and connected brain regions. During LIFU visits, participants will complete the Multi-Source Interference Task to assess cognitive control. EEG and fMRI may also be collected to evaluate neurocircuitry changes associated with LIFU.
The primary objective is to evaluate the effect of LIFU on cognitive control and associated circuitry. The study will also examine the time course of this effect, whether responses differ by baseline cognitive control circuit function, and whether changes in circuitry relate to self-reported experiences.
- Being tested
- DIADEM Low-Intensity Focused Ultrasound Neuromodulation
- Keywords
- Suicide-related Experience Reduction via Enhancement of Neuroplasticity, DIADEM, Neuromodulation, Anterior limb of the internal capsule, Low-intensity focused ultrasound
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIADEM Low-Intensity Focused Ultrasound NeuromodulationDevice
Also called SPIRE DIADEM System, LIFU Neuromodulation
Low-intensity focused ultrasound neuromodulation will be delivered using the SPIRE DIADEM device. LIFU will be applied to subregions of deep brain circuitry involved in cognitive control, including regions within the dorsal or ventral internal capsule, surrounding striatal nuclei, and/or connected brain areas. Stimulation will be delivered by trained study staff according to device safety and screening procedures.
| Study group | Role | What they receive |
|---|---|---|
| DIADEM LIFU Neuromodulation | Experimental | Participants will receive low-intensity focused ultrasound neuromodulation using the DIADEM device while completing cognitive control tasks. Stimulation may be applied to subregions of the internal capsule and connected brain regions to identify targets that modulate cognitive control performance or circuitry. Receives: Device: DIADEM Low-Intensity Focused Ultrasound Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Reaction Time During the Multi-Source Interference Task Following LIFU at Different Internal Capsule Sites
Cognitive control performance will be assessed using the Multi-Source Interference Task (MSIT), a computerized cognitive control task. Reaction time will be measured in milliseconds. The MSIT will be administered in blocks, with one block corresponding to each internal capsule sonication site. Mean reaction time will be calculated separately for each block and compared with baseline MSIT mean reaction time. Lower reaction times indicate faster task performance.
Measured: Baseline and during MSIT task blocks corresponding to each internal capsule LIFU sonication site
Event-Related EEG Alpha-Band Spectral Power Following LIFU
EEG alpha-band activity will be assessed using event-related spectral power during the Multi-Source Interference Task (MSIT) following LIFU. Spectral power will be baseline-normalized using a pre-stimulus reference interval from -500 to -100 milliseconds relative to the target event. Baseline normalization will be performed in the linear power domain, with results expressed in decibels (dB).
Measured: During post-LIFU MSIT assessment at each internal capsule sonication site
Event-Related EEG Theta-Band Spectral Power Following LIFU
EEG theta-band activity will be assessed using event-related spectral power during the Multi-Source Interference Task (MSIT) following LIFU. Spectral power will be baseline-normalized using a pre-stimulus reference interval from -500 to -100 milliseconds relative to the target event. Baseline normalization will be performed in the linear power domain, with results expressed in decibels (dB).
Measured: During post-LIFU MSIT assessment at each internal capsule sonication site
Time Course of Mean Reaction Time During the Multi-Source Interference Task Following LIFU
The time course of LIFU effects on cognitive control will be evaluated using repeated mean reaction time measurements obtained during the Multi-Source Interference Task (MSIT). Reaction time will be measured in milliseconds and summarized for each assessment block. Mean reaction time will be compared across the repeated assessments to evaluate changes in cognitive control performance over time. Lower values indicate faster task performance.
Measured: During repeated MSIT assessments across LIFU sonication sessions and through post-treatment follow-up within 2 weeks
Secondary outcomes (9)
Change in MSIT Mean Reaction Time From Baseline Following LIFU at Different Internal Capsule Sites
Differential response to LIFU across internal capsule stimulation sites will be assessed using mean reaction time during the Multi-Source Interference Task (MSIT), measured in milliseconds. Mean reaction time will be calculated separately for the MSIT block corresponding to each sonication site. Change will be calculated as the mean reaction time following sonication at each site minus the baseline mean reaction time. Negative change values indicate faster responses relative to baseline. Changes will be compared across sonication sites.
Measured: Baseline and during MSIT task blocks corresponding to each internal capsule LIFU sonication site
Change in Momentary Active Suicidal Ideation Rating Measured by Ecological Momentary Assessment
Momentary active suicidal ideation will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5.
Measured: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Passive Suicidal Ideation Rating Measured by Ecological Momentary Assessment
Momentary passive suicidal ideation will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5.
Measured: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Depression Rating Measured by Ecological Momentary Assessment
Momentary depressive symptoms will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5.
Measured: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Rumination Rating Measured by Ecological Momentary Assessment
Momentary rumination will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5.
Measured: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Physical Pain Rating Measured by Ecological Momentary Assessment
Momentary physical pain will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5.
Measured: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Co-dampening Rating Measured by Ecological Momentary Assessment
Momentary co-dampening will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5.
Measured: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Hallucination Rating Measured by Ecological Momentary Assessment
Momentary experiences of hallucinations will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5.
Measured: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Persecutory Experience Rating Measured by Ecological Momentary Assessment
Momentary persecutory experiences will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5.
Measured: Twice daily for 3 days before and 3 days after LIFU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion20 Sep 2028 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This experimental study will enroll adults with a lifetime history of suicide attempt or suicidal ideation, no current suicidality, and varying levels of cognitive control circuit function. Participants will complete screening, cognitive control tasks, MRI/fMRI, ecological momentary assessments, and low-intensity focused ultrasound neuromodulation using the DIADEM system. LIFU will be applied to deep brain regions involved in cognitive control while participants complete the Multi-Source Interference Task and related neurocognitive measures.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael V Bronstein, PhD, Principal investigator, University of MinnesotaAlik S Widge, MD,PhD, Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923461
- Sponsor's protocol ID
- STUDY00028755
- Status last verified
- Nov 2026
- First submitted
- 13 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide-related Experience Reduction Via Enhancement of Neuroplasticity
- ClinicalTrials.gov ID
- NCT07923461
- Acronym / sponsor ID
- STUDY00028755
- Keywords
- Suicide-related Experience Reduction via Enhancement of Neuroplasticity, DIADEM, Neuromodulation, Anterior limb of the internal capsule, Low-intensity focused ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 20 Sep 2028 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 6 Nov 2026 (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.
SERENE is an experimental study evaluating low-intensity focused ultrasound neuromodulation of cognitive control circuitry in adults with a lifetime history of suicide attempt or suicidal ideation, but without current suicidality.
Participants will complete screening, cognitive control tasks, MRI/fMRI, ecological momentary assessments, and low-intensity focused ultrasound neuromodulation using the DIADEM system. The study will examine whether low-intensity focused ultrasound (LIFU) neuromodulation changes cognitive control performance measured by the Multi-Source Interference Task (MSIT) and EEG event-related spectral power in the alpha and theta frequency bands.
The study will also examine the time course of LIFU effects and explore whether changes in cognitive control circuitry relate to self-reported experiences, including mood, anxiety, psychosis symptoms, suicidal ideation, and emotion regulation.
Detailed description
SERENE is an experimental study designed to test a personalized, non-invasive neuromodulation technique to investigate the neural basis of cognitive control.
The study will enroll adults with a lifetime history of suicide attempt or suicidal ideation, but without current suicidal ideation or behavior. Participants will be screened using the Columbia-Suicide Severity Rating Scale to confirm suicide history and exclude current suicidality. Participants will also complete MRI/fMRI-based cognitive control screening to identify cognitive control circuit function.
Participants will complete baseline cognitive and self-report assessments, including computerized cognitive tasks and clinical/self-report measures. Ecological momentary assessments will be completed before and after neuromodulation to assess symptoms and daily-life experiences related to cognitive control, including mood, anxiety, psychosis-related symptoms, suicidal ideation, and emotion regulation.
The study intervention is low-intensity focused ultrasound neuromodulation delivered using the DIADEM system. LIFU will be applied to deep brain regions involved in cognitive control, including subregions of the internal capsule and connected brain regions. During LIFU visits, participants will complete the Multi-Source Interference Task to assess cognitive control. EEG and fMRI may also be collected to evaluate neurocircuitry changes associated with LIFU.
The primary objective is to evaluate the effect of LIFU on cognitive control and associated circuitry. The study will also examine the time course of this effect, whether responses differ by baseline cognitive control circuit function, and whether changes in circuitry relate to self-reported experiences.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This experimental study will enroll adults with a lifetime history of suicide attempt or suicidal ideation, no current suicidality, and varying levels of cognitive control circuit function. Participants will complete screening, cognitive control tasks, MRI/fMRI, ecological momentary assessments, and low-intensity focused ultrasound neuromodulation using the DIADEM system. LIFU will be applied to deep brain regions involved in cognitive control while participants complete the Multi-Source Interference Task and related neurocognitive measures.
| Arm | Type | Receives |
|---|---|---|
| DIADEM LIFU Neuromodulation | Experimental | Device: DIADEM Low-Intensity Focused Ultrasound NeuromodulationParticipants will receive low-intensity focused ultrasound neuromodulation using the DIADEM device while completing cognitive control tasks. Stimulation may be applied to subregions of the internal capsule and connected brain regions to identify targets that modulate cognitive control performance or circuitry. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lifetime history of suicide attempt or suicidal ideation, as determined by the Columbia-Suicide Severity Rating Scale
- Score in specified ranges on measures of cognitive control behavior and/or cognitive control circuit function
- No current suicide ideation or behavior within the past 3 months, as determined by the Columbia-Suicide Severity Rating Scale
- Age 18 to 65 years
- Speaks and understands English
Key exclusion criteria (21 listed)
- Under age 18
- Neurological disorder that may affect fMRI scan results or cause reaction to LIFU to differ from healthy adults
- Regular use of psychoactive medication, except PRN use if the participant is willing and able to abstain during the study period
- Psychiatric hospitalization within the past 3 months
- Contraindication to fMRI scanning, including claustrophobia, unremovable piercings, pregnancy, medical devices such as pacemakers, or a movement or sleep disorder
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 Low-Intensity Focused Ultrasound NeuromodulationAlso: SPIRE DIADEM System, LIFU NeuromodulationLow-intensity focused ultrasound neuromodulation will be delivered using the SPIRE DIADEM device. LIFU will be applied to subregions of deep brain circuitry involved in cognitive control, including regions within the dorsal or ventral internal capsule, surrounding striatal nuclei, and/or connected brain areas. Stimulation will be delivered by trained study staff according to device safety and screening procedures. | Device | DIADEM LIFU Neuromodulation |
Primary outcome
Mean Reaction Time During the Multi-Source Interference Task Following LIFU at Different Internal Capsule Sites
Time frame: Baseline and during MSIT task blocks corresponding to each internal capsule LIFU sonication site
Cognitive control performance will be assessed using the Multi-Source Interference Task (MSIT), a computerized cognitive control task. Reaction time will be measured in milliseconds. The MSIT will be administered in blocks, with one block corresponding to each internal capsule sonication site. Mean reaction time will be calculated separately for each block and compared with baseline MSIT mean reaction time. Lower reaction times indicate faster task performance.
Event-Related EEG Alpha-Band Spectral Power Following LIFU
Time frame: During post-LIFU MSIT assessment at each internal capsule sonication site
EEG alpha-band activity will be assessed using event-related spectral power during the Multi-Source Interference Task (MSIT) following LIFU. Spectral power will be baseline-normalized using a pre-stimulus reference interval from -500 to -100 milliseconds relative to the target event. Baseline normalization will be performed in the linear power domain, with results expressed in decibels (dB).
Event-Related EEG Theta-Band Spectral Power Following LIFU
Time frame: During post-LIFU MSIT assessment at each internal capsule sonication site
EEG theta-band activity will be assessed using event-related spectral power during the Multi-Source Interference Task (MSIT) following LIFU. Spectral power will be baseline-normalized using a pre-stimulus reference interval from -500 to -100 milliseconds relative to the target event. Baseline normalization will be performed in the linear power domain, with results expressed in decibels (dB).
Time Course of Mean Reaction Time During the Multi-Source Interference Task Following LIFU
Time frame: During repeated MSIT assessments across LIFU sonication sessions and through post-treatment follow-up within 2 weeks
The time course of LIFU effects on cognitive control will be evaluated using repeated mean reaction time measurements obtained during the Multi-Source Interference Task (MSIT). Reaction time will be measured in milliseconds and summarized for each assessment block. Mean reaction time will be compared across the repeated assessments to evaluate changes in cognitive control performance over time. Lower values indicate faster task performance.
9 secondary outcomes
Change in MSIT Mean Reaction Time From Baseline Following LIFU at Different Internal Capsule Sites
Time frame: Baseline and during MSIT task blocks corresponding to each internal capsule LIFU sonication site
Change in Momentary Active Suicidal Ideation Rating Measured by Ecological Momentary Assessment
Time frame: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Passive Suicidal Ideation Rating Measured by Ecological Momentary Assessment
Time frame: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Depression Rating Measured by Ecological Momentary Assessment
Time frame: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Rumination Rating Measured by Ecological Momentary Assessment
Time frame: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Physical Pain Rating Measured by Ecological Momentary Assessment
Time frame: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Co-dampening Rating Measured by Ecological Momentary Assessment
Time frame: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Hallucination Rating Measured by Ecological Momentary Assessment
Time frame: Twice daily for 3 days before and 3 days after LIFU
Change in Momentary Persecutory Experience Rating Measured by Ecological Momentary Assessment
Time frame: Twice daily for 3 days before and 3 days after LIFU
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 6 Nov 2026.
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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.
Michael V Bronstein, PhD principal investigator
University of Minnesota
Alik S Widge, MD,PhD study director
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIADEM Low-Intensity Focused Ultrasound Neuromodulation in people with Suicidal Ideation and Cognitive Control, run by University of Minnesota 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 6 inclusion and 21 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: opening soon, as of the sponsor's last update on 6 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Michael V Bronstein, PhD (781-492-5644, brons139@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Reaction Time During the Multi-Source Interference Task Following LIFU at Different Internal Capsule Sites (time frame: Baseline and during MSIT task blocks corresponding to each internal capsule LIFU sonication site). 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?
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 6 Nov 2026.