Treatment-Resistant DepressionLIFU CANVASNCT07166289
Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression
A study testing Low-intensity focused ultrasound in people with Treatment-Resistant Depression, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
Approximately one third of individuals with Major Depressive Disorder (MDD) are considered treatment-resistant, subject to severe disability and risk of suicide, and exhibit symptoms anchored in abnormalities of Research Domain Criteria (RDoC) Negative Valence Systems behavioral processes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-Resistant Depression
- What is being tested?
- Low-intensity focused ultrasound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to Jul 2030
- 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
- Persons 18-65 years old, with sex and ethnicity recruitment targets including a M:F proportion of 1:2 and White:Black:Hispanic:Native American proportion as close as possible to 8:2:2:1 to reflect the regional epidemiology of TRD (63% White American; 16% African American; 14% Hispanic of any race; 5% Native American),
- DSM-5-TR diagnosis of MDD as confirmed by MINI structured interview followed by consultation with a board-certified psychiatrist,
- Evidence of treatment resistance defined as continued MDD symptoms despite any of the following:
- two or more adequate (6 week) trials of antidepressants with different mechanisms,
- evidence-based psychotherapy,
- augmentation agent (lithium, atypical antipsychotic, or T3), or
Show all 11Show fewer
- consideration of ECT or prior ECT nonresponse or intolerance,
- at least moderate symptoms as indicated by MADRS≥20 upon screening
- stable treatments including psychotherapy and medication for at least six weeks prior to participation.
- Fluent English speaker, capable of written consent
- Consent that random observations of pathology are possible (e.g., brain abnormality seen during imaging)
Who cannot join
- Clinical history of at least minor neurocognitive disorder of neurodegenerative origin,
- PROMIS (Cognitive Function scale) score ≤40 (i.e., mean - 1SD), collected at baseline
- clinical history of relevant structural pathology of the central nervous system, including Parkinson's disease, multiple sclerosis, and brain malignant neoplasia,
- uncontrolled diabetes mellitus (as evidenced by a fasting glycemia ≥ 120 mg/dL or hemoglobin A1c ≥ 6.5%) or hypertension (as evidenced by two consecutive readings ≥ 140/90 mmHg) to ensure medical stability, collected at baseline
- pregnancy or lactation,
- Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, amphetamine/methamphetamine, and ecstasy), or substance use disorder including alcohol, stimulants, sedatives, and cannabis exceeding mild severity in the last 6 months,
Show all 17Show fewer
- active suicidal ideation (as measured by Suicide-Risk-Assessment-C-SSRS75 "Yes" answers to items 3, 4 or 5 of Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months, collected at baseline
- MRI contraindications as detected by the MRI Safety Screen, including unwillingness/unable to complete MRI scans
- medical history indicative of moderate to severe traumatic brain injury as evidenced by history of > 5 minutes of loss of consciousness, or of skull fractures, which in theory could distort LIFU tissue propagation, and
- a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia or bulimia nervosa), learning disability, or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g., narcissistic personality disorder, borderline personality disorder).
- Has a history of moderate or severe substance or alcohol use disorder according to DSM-5-TR
- Use of benzodiazepines or anticonvulsants in the 7 days prior ot screening
- Medical, psychiatric, or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study.
- No reliable method of communication (i.e., no access to internet or phone connection)
- Prescription of a medication outside of the accepted range, as determined by best clinical practices and current research
- Unwilligness or inability to complete any of the major aspects of the study protocol
- Non-correctable vision or hearing problems
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
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
Salvador M Guinjoan, MD, PhD, 918-502-5119, sguinjoan@laureateinstitute.org
Danielle E Clark, MA, 918-701-9610, dclark@laureateinstitute.org
About this study
Official title: Parsing Mechanistic Relationships Between Circuits and Negative Valence System Behaviors in Treatment-Resistant Depression With Ultrasound Neuromodulation
Approximately one third of individuals with Major Depressive Disorder (MDD) are considered treatment-resistant, subject to severe disability and risk of suicide, and exhibit symptoms anchored in abnormalities of Research Domain Criteria (RDoC) Negative Valence Systems behavioral processes. In the present study we plan to use low-intensity focused ultrasound in 120 persons with treatment-resistant MDD to modulate deep white matter tracts connecting the thalamus and different regions of the prefrontal cortex reversibly and non-invasively, with the aim of assigning a causal, mechanistic role to large scale brain circuits in the production of those critical behavioral abnormalities. A successful study will help to attain the precise definition of neuromodulation targets for this clinical population in utter need of help.
Read the detailed description
Approximately one third of individuals with depression are considered treatment-resistant (TRD) and exhibit symptoms anchored in abnormalities of RDoC Negative Valence Systems behavioral processes. For example, anhedonia and rumination contribute to significant impairment in daily functioning, high relapse rates, and a staggering global toll of over 700,000 annual suicides. One reason for inadequate treatment response is our limited understanding of causal mechanisms linking brain circuit function to Negative Valence behavior abnormalities, which impedes the development of precision neuromodulation treatments. The investigators propose to address this problem by using low-intensity focused ultrasound (LIFU), which can noninvasively and reversibly modulate deep brain circuits, to determine the mechanistic relationship between cortico-subcortical circuits and distinct Negative Valence System behaviors including reward processes and rumination. Substantial preliminary evidence suggests that aberrant connectivity between the thalamus and orbitofrontal (OFC) or anterior cingulate (ACC) cortices in the right hemisphere contribute to distinct depression-related RDoC Negative Valence system behavioral changes. In a preliminary clinical trial, which received a non-significant risk determination by the FDA (NCT05697172) the investigators observed safe modulation of deep white matter tracts using LIFU. The investigators now propose to employ advanced structural imaging techniques to tailor modulation targets to each patient's unique anatomy.
The study will involve 120 TRD participants who will receive LIFU and sham stimulation to individually defined white matter tracts connecting thalamus with either OFC (n=60) or ACC (n=60). The investigators will measure resting-state functional magnetic resonance imaging (fMRI) changes, and changes in two behavioral models underlying Negative Valence manifestations (monetary incentive delay and induced rumination tasks). The investigators' hypothesis is that thalamo-OFC and thalamo-ACC hyperconnectivity, historically targeted in neuromodulation techniques useful in TRD, contributes to distortions in distinct behavioral components of the Negative Valence system. This proposal thus has the following Specific Aims: In Aim 1, the investigators will determine the anatomical specificity of LIFU when applied to thalamo-OFC and thalamo-ACC white matter tracts. The investigators predict that LIFU will lead to reduced functional connectivity in the specific cortical regions reached by the modulated white matter bundles. In Aim 2, the investigators will correlate connectivity between thalamus and OFC or ACC, with functional features of distinct behaviors pertaining to the RDoC Negative Valence. Exploratory Aim 3 will establish behavioral correlates of such neural changes. If successful, the present proposal will contribute to understanding clinically meaningful brain-behavior mechanistic relationships by parsing thalamo-prefrontal circuits and RDoC Negative Valence system behaviors. In turn, such definition of targets with a causal role in abnormal behavior processes, could inform precision therapeutic neuromodulation in a psychiatric population in utter need of innovative treatments.
- Conditions
- Treatment-Resistant Depression
- Being tested
- Low-intensity focused ultrasound
- Keywords
- Treatment-Resistant Depression, Low-Intensity Focused Ultrasound
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity focused ultrasoundOther
80-second stimulus with an estimated tissue ISSPA=2.26 W/cm2, with (sham) or without (verum) interposition of Sorbothane film
| Study group | Role | What they receive |
|---|---|---|
| Thalamo-Anterior Cingulate Cortex Tract LIFU Sonication | Experimental | An 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). It is estimated a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore the investigators will set the free-field Intensity Spatial-Peak Pulse-Average (ISPPA) at 9.04 Watt /cm2 or 518 kPascal (to achieve 2.26 Watt/cm2 estimated derated ISPPA). Any modeling of actual energy delivery will be made a posteriori employing BabelBrain® software embedded in the Brainsight® neuronavigation system. Receives: Other: Low-intensity focused ultrasound |
| Thalamo- Orbitofrontal Cortex Tract LIFU Sonication | Experimental | An 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). It is estimated a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore the investigators will set the free-field Intensity Spatial-Peak Pulse-Average (ISPPA) at 9.04 Watt /cm2 or 518 kPascal (to achieve 2.26 Watt/cm2 estimated derated ISPPA). Any modeling of actual energy delivery will be made a posteriori employing BabelBrain® software embedded in the Brainsight® neuronavigation system. Receives: Other: Low-intensity focused ultrasound |
| Sham LIFU | Sham comparator | An 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). It is estimated a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore the investigators will set the free-field Intensity Spatial-Peak Pulse-Average (ISPPA) at 9.04 Watt /cm2 or 518 kPascal (to achieve 2.26 Watt/cm2 estimated derated ISPPA). Any modeling of actual energy delivery will be made a posteriori employing BabelBrain® software embedded in the Brainsight® neuronavigation system. Receives: Other: Low-intensity focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Sonication Changes in Functional Connectivity
Changes in resting-state functional (fMRI) connectivity (FC) between thalamus and either Anterior Cingulate (ACC) or Orbitofrontal (OFC) cortices after LIFU or Sham stimulation.
Measured: Pre- vs up to 30 minutes post-sonication or sham intervention.
Post-Sonication Changes in Reward and Repetitive Mentation
Changes in BOLD activation of either Anterior Cingulate (ACC) or Orbitofrontal Cortex (OFC) during Monetary Incentive Delay and Induced Rumination Tasks corresponding to changes in reward and repetitive thinking, respectively.
Measured: Up to 30 minutes post-sonication vs sham intervention
Secondary outcomes (1)
Post-Sonication Changes in Functional Connectivity and Anhedonic and Ruminative Symptoms
Changes in functional connectivity of thalamo-frontal and thalamo-anteiror cingulate regions and the correlation to changes in Snaith-Hamilton Pleasure Scale scores (minimum score: 0; maximum score: 14; lower scores mean better outcomes) and Brief State Rumination Inventory Scores (minimum value: 0; maximum value: 25; lower scores mean better outcomes) to evaluate anhedonic and ruminative symptoms respectively.
Measured: Pre- vs up to 30 minutes post-sonication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start30 Sep 2025
- Primary completionApr 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-Resistant DepressionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166289
- Sponsor's protocol ID
- 2024-011
- Acronym
- LIFU CANVAS
- Status last verified
- Feb 2026
- First submitted
- 3 Sep 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parsing Mechanistic Relationships Between Circuits and Negative Valence System Behaviors in Treatment-Resistant Depression With Ultrasound Neuromodulation
- ClinicalTrials.gov ID
- NCT07166289
- Acronym / sponsor ID
- LIFU CANVAS / 2024-011
- Conditions
- Treatment-Resistant Depression
- Keywords
- Treatment-Resistant Depression, Low-Intensity Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 10 Sep 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.
Approximately one third of individuals with Major Depressive Disorder (MDD) are considered treatment-resistant, subject to severe disability and risk of suicide, and exhibit symptoms anchored in abnormalities of Research Domain Criteria (RDoC) Negative Valence Systems behavioral processes. In the present study we plan to use low-intensity focused ultrasound in 120 persons with treatment-resistant MDD to modulate deep white matter tracts connecting the thalamus and different regions of the prefrontal cortex reversibly and non-invasively, with the aim of assigning a causal, mechanistic role to large scale brain circuits in the production of those critical behavioral abnormalities. A successful study will help to attain the precise definition of neuromodulation targets for this clinical population in utter need of help.
Detailed description
Approximately one third of individuals with depression are considered treatment-resistant (TRD) and exhibit symptoms anchored in abnormalities of RDoC Negative Valence Systems behavioral processes. For example, anhedonia and rumination contribute to significant impairment in daily functioning, high relapse rates, and a staggering global toll of over 700,000 annual suicides. One reason for inadequate treatment response is our limited understanding of causal mechanisms linking brain circuit function to Negative Valence behavior abnormalities, which impedes the development of precision neuromodulation treatments. The investigators propose to address this problem by using low-intensity focused ultrasound (LIFU), which can noninvasively and reversibly modulate deep brain circuits, to determine the mechanistic relationship between cortico-subcortical circuits and distinct Negative Valence System behaviors including reward processes and rumination. Substantial preliminary evidence suggests that aberrant connectivity between the thalamus and orbitofrontal (OFC) or anterior cingulate (ACC) cortices in the right hemisphere contribute to distinct depression-related RDoC Negative Valence system behavioral changes. In a preliminary clinical trial, which received a non-significant risk determination by the FDA (NCT05697172) the investigators observed safe modulation of deep white matter tracts using LIFU. The investigators now propose to employ advanced structural imaging techniques to tailor modulation targets to each patient's unique anatomy.
The study will involve 120 TRD participants who will receive LIFU and sham stimulation to individually defined white matter tracts connecting thalamus with either OFC (n=60) or ACC (n=60). The investigators will measure resting-state functional magnetic resonance imaging (fMRI) changes, and changes in two behavioral models underlying Negative Valence manifestations (monetary incentive delay and induced rumination tasks). The investigators' hypothesis is that thalamo-OFC and thalamo-ACC hyperconnectivity, historically targeted in neuromodulation techniques useful in TRD, contributes to distortions in distinct behavioral components of the Negative Valence system. This proposal thus has the following Specific Aims: In Aim 1, the investigators will determine the anatomical specificity of LIFU when applied to thalamo-OFC and thalamo-ACC white matter tracts. The investigators predict that LIFU will lead to reduced functional connectivity in the specific cortical regions reached by the modulated white matter bundles. In Aim 2, the investigators will correlate connectivity between thalamus and OFC or ACC, with functional features of distinct behaviors pertaining to the RDoC Negative Valence. Exploratory Aim 3 will establish behavioral correlates of such neural changes. If successful, the present proposal will contribute to understanding clinically meaningful brain-behavior mechanistic relationships by parsing thalamo-prefrontal circuits and RDoC Negative Valence system behaviors. In turn, such definition of targets with a causal role in abnormal behavior processes, could inform precision therapeutic neuromodulation in a psychiatric population in utter need of innovative treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thalamo-Anterior Cingulate Cortex Tract LIFU Sonication | Experimental | Other: Low-intensity focused ultrasoundAn 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). It is estimated a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore the investigators will set the free-field Intensity Spatial-Peak Pulse-Average (ISPPA) at 9.04 Watt /cm2 or 518 kPascal (to achieve 2.26 Watt/cm2 estimated derated ISPPA). Any modeling of actual energy delivery will be made a posteriori employing BabelBrain® software embedded in the Brainsight® neuronavigation system. |
| Thalamo- Orbitofrontal Cortex Tract LIFU Sonication | Experimental | Other: Low-intensity focused ultrasoundAn 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). It is estimated a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore the investigators will set the free-field Intensity Spatial-Peak Pulse-Average (ISPPA) at 9.04 Watt /cm2 or 518 kPascal (to achieve 2.26 Watt/cm2 estimated derated ISPPA). Any modeling of actual energy delivery will be made a posteriori employing BabelBrain® software embedded in the Brainsight® neuronavigation system. |
| Sham LIFU | Sham comparator | Other: Low-intensity focused ultrasoundAn 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). It is estimated a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore the investigators will set the free-field Intensity Spatial-Peak Pulse-Average (ISPPA) at 9.04 Watt /cm2 or 518 kPascal (to achieve 2.26 Watt/cm2 estimated derated ISPPA). Any modeling of actual energy delivery will be made a posteriori employing BabelBrain® software embedded in the Brainsight® neuronavigation system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Persons 18-65 years old, with sex and ethnicity recruitment targets including a M:F proportion of 1:2 and White:Black:Hispanic:Native American proportion as close as possible to 8:2:2:1 to reflect the regional epidemiology of TRD (63% White American; 16% African American; 14% Hispanic of any race; 5% Native American),
- DSM-5-TR diagnosis of MDD as confirmed by MINI structured interview followed by consultation with a board-certified psychiatrist,
- Evidence of treatment resistance defined as continued MDD symptoms despite any of the following:
- at least moderate symptoms as indicated by MADRS≥20 upon screening
- stable treatments including psychotherapy and medication for at least six weeks prior to participation.
Key exclusion criteria (17 listed)
- Clinical history of at least minor neurocognitive disorder of neurodegenerative origin,
- PROMIS (Cognitive Function scale) score ≤40 (i.e., mean - 1SD), collected at baseline
- clinical history of relevant structural pathology of the central nervous system, including Parkinson's disease, multiple sclerosis, and brain malignant neoplasia,
- uncontrolled diabetes mellitus (as evidenced by a fasting glycemia ≥ 120 mg/dL or hemoglobin A1c ≥ 6.5%) or hypertension (as evidenced by two consecutive readings ≥ 140/90 mmHg) to ensure medical stability, collected at baseline
- pregnancy or lactation,
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 |
|---|---|---|
| Low-intensity focused ultrasound80-second stimulus with an estimated tissue ISSPA=2.26 W/cm2, with (sham) or without (verum) interposition of Sorbothane film | Other | Sham LIFU, Thalamo- Orbitofrontal Cortex Tract LIFU Sonication, Thalamo-Anterior Cingulate Cortex Tract LIFU Sonication |
Primary outcome
Post-Sonication Changes in Functional Connectivity
Time frame: Pre- vs up to 30 minutes post-sonication or sham intervention.
Changes in resting-state functional (fMRI) connectivity (FC) between thalamus and either Anterior Cingulate (ACC) or Orbitofrontal (OFC) cortices after LIFU or Sham stimulation.
Post-Sonication Changes in Reward and Repetitive Mentation
Time frame: Up to 30 minutes post-sonication vs sham intervention
Changes in BOLD activation of either Anterior Cingulate (ACC) or Orbitofrontal Cortex (OFC) during Monetary Incentive Delay and Induced Rumination Tasks corresponding to changes in reward and repetitive thinking, respectively.
1 secondary outcome
Post-Sonication Changes in Functional Connectivity and Anhedonic and Ruminative Symptoms
Time frame: Pre- vs up to 30 minutes post-sonication
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 2 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity focused ultrasound in people with Treatment-Resistant Depression, run by Laureate Institute for Brain Research, Inc. 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 11 inclusion and 17 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 2 Mar 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.
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 Salvador M Guinjoan, MD, PhD (918-502-5119, sguinjoan@laureateinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Sonication Changes in Functional Connectivity (time frame: Pre- vs up to 30 minutes post-sonication or sham intervention.). The study lists 2 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 2 Mar 2026.