Major Depressive DisorderNCT05697172
Low Intensity Ultrasound Neuromodulation of Repetitive Negative Thinking In Depression
A study testing Low-intensity focused ultrasound in people with Major Depressive Disorder, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
The investigators propose to use low-intensity transcranial focused ultrasound (LIFU), a novel neuromodulation method, to probe the causal involvement of individually defined components of an anteromedial brain circuit in the processing of self-referential thoughts, and the production of repetitive negative thinking… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Low-intensity focused ultrasound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 6 Feb 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prior participation in the CoBRE study (WIRB Protocol #20182352) and selected as a component of the propensity-matched sample of patients with major depression and varying intensities of RNT (in the form of Ruminative Response Scale (RRS) score; n=20), or healthy individuals with no psychiatric diagnosis (n=10), OR In the unexpected event that not enough participants can be recruited who meet criterion 1 (only 1 out of 6 studied patients would be incorporated into this study), participants will be newly recruited from newly recruited patients from the community or from the Mood and Anxiety Disorders inpatient unit at Laureate Psychiatric Hospital and Clinic.
- A Patient Health Questionnaire (PHQ-9) score ≥ 10 at enrollment.
- Provision of signed and dated informed consent form.
- Subject provides verifiable contact information (name, telephone number(s), email and mailing address) for at least 2 persons who agree to be contacted by study personnel as deemed necessary.
- Subject is followed by a licensed physician or a licensed mental health care provider (i.e., psychologist, LCSW) throughout study participation outside of LIBR.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
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- Male or female, aged 18 to 65 years.
- In good current general health as evidenced by medical history.
- Ability to comply with the study chronogram.
- For females of reproductive potential: negative urine pregnancy screening test.
Who cannot join
- Current use (within the last 30 days) of drugs of abuse or moderate / severe alcohol use disorder.
- Lifetime diagnosis of schizophrenia spectrum disorder, other nonaffective psychotic disorders, or bipolar disorders.
- Presence of cardiac pacemaker or any other MRI contraindication.
- Pregnancy or lactation.
- Febrile illness within the last two weeks.
- Treatment with an investigational drug or participation in any other interventional research protocol in the last 2 weeks.
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- The participant is unable to understand the goal of the study, instructions, or the risks associated with the study as judged by a clinically trained assessment team member.
- Clinical and/or imaging evidence of vascular, traumatic, or neurodegenerative disorders of the central nervous system (CNS), or other neurological disorders potentially compromising patient's participation in the study, or study results. This includes, but it is not limited to, any minor or major neurocognitive disorder including those caused by traumatic brain injury, Parkinson's disease, significant small-vessel disease, multiple sclerosis, Huntington's disease, early-onset Alzheimer's disease, chronic infections of the CNS or the meninges, previous chronic use of alcohol or CVA sequelae, or a Montreal Cognitive Assessment (MoCA) score <25 due to any cause. The PI can decide if a potential participant needs to be excluded due to some other cause of structural or functional compromise of the CNS (e.g., epilepsy).
- Active suicidal ideation (as measured by Suicide-Risk-Assessment-C-SSRS "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 year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Official title: Neuromodulation of Circuits Underlying Repetitive Negative and Self-Referential Thinking in Depression: An Early Feasibility Study Employing Transcranial Focused Ultrasound
The investigators propose to use low-intensity transcranial focused ultrasound (LIFU), a novel neuromodulation method, to probe the causal involvement of individually defined components of an anteromedial brain circuit in the processing of self-referential thoughts, and the production of repetitive negative thinking (RNT), a prominent transdiagnostic manifestation with adverse clinical consequences. The investigators hypothesize that real vs. sham low-intensity sonication of individually-defined anteromedial structures connecting medial orbitofrontal and anterior cingulate cortices with ventral striatum and anterior thalamus will show reduced initiation or maintenance of RNT as measured by (1) Brief State Rumination Inventory (BSRI) scores and distress associated to repetitive negative thoughts, and (2) improvement of the affective valence associated to self-referential adjectives, and that these changes will be associated with decreased connectivity between structures mentioned above. The present early feasibility study is an initial step that aims to determine its feasibility and help with the planning of a larger study addressed at actual hypothesis testing.
Read the detailed description
Depression represents a remarkable public health burden, accounting for a large amount of disability and societal costs, comparable to prevalent diseases in other areas of medicine. This is partly due to unsatisfactory outcomes of well-established therapies, including psychotropic drugs and different types of psychotherapy. As a response to this problem, therapeutics in psychiatry is moving from drug manipulation of neurotransmitter systems to modulation of brain circuits selectively involved in specific symptoms of depression. These efforts have been partially hampered, however, by heterogeneity of clinical manifestations in these disorders, such that different symptoms are hypothesized to be maintained by specific circuit-level dysfunctions, as well as by significant interindividual variation in those brain circuits, which calls for personalized approaches to achieve their successful modulation. Thus far, the efforts to accomplish individualized and precise modulation of aberrant circuits responsible for the expression of depression and anxiety symptoms have encountered three important, mutually related problems. First, widely available noninvasive neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have poor spatial resolution and only reach superficial areas of the brain, which impedes the precise modulation of circuits that involve deep, minute subcortical gray matter structures and/or white matter connecting tracts. Second, surgical deep-brain stimulation procedures are more accurate but are too costly and risky to be implemented in any moderately sized proof-of-concept study at present. Third, it is unlikely that modification of the activity of a discrete brain circuit will target the entire complex behavioral macro of major depression. The investigators therefore chose to target a single measurable and replicable construct of depression, repetitive negative thinking (RNT). RNT is a transdiagnostic clinical manifestation that cuts across a variety of internalizing psychiatric disorders, but in the case of depression, it is associated with persistent symptoms, treatment resistance, proneness to relapse after treatment, and more suicidal ideation, behavior, and completed suicides. With the help of an emerging technology device recently acquired by LIBR, which can produce focused, reversible and noninvasive neuromodulation in deep brain structures (low-intensity transcranial focused ultrasound, tfUS), the investigators will probe the causal role of individually-identified circuits in the modulation of (a) the generation and maintenance of repetitive negative thinking (RNT), and (b) affective processing of self-referential adjectives. Specifically, the investigators will put to test the hypotheses that RNT and the affective load of self-referential adjectives can be improved by modulating components of an anteromedial brain circuit, identified on an individual basis as associated with high levels of RNT. Therefore, this project has two distinct phases. First, the investigators will use advanced structural-functional connectivity analysis techniques to define anatomical tracts that support functional connectivity alterations associated with high RNT. The investigators will refine and adjust results of whole-brain analyses, by focusing also on overlapping anatomical components of tracts pertaining to three well-established, historical psychosurgical targets of antidepressant and obsessional thinking treatment. Second, the investigators will employ the resulting regions of interest to inform the choice of the target(s) for tfUS neuromodulation, probing its effects on 1) neural processing of self-referential affective adjectives, 2) functional connectivity between regions known to have an anatomical connection in the individual participant, and 3) measures of RNT and clinical depression, including the degree of distress associated to the thought/s subjected to RNT. The investigators are in an ideal position to accomplish these objectives, given their experience with clinical management of these disorders, with the use of neuromodulation techniques, and expertise in the use of state-of-the-art structural and functional neuroimaging techniques, psychophysiological tools, and computational psychiatry methods.
- Conditions
- Major Depressive Disorder
- Being tested
- Low-intensity focused ultrasound
- Keywords
- Repetitive Negative Thinking, Low-Intensity Focused Ultrasound, Major Depression
- Medical subject headings
- Depressive Disorder, Major
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 |
|---|---|---|
| Active Low Intensity Focused Ultrasound (LIFU) | Experimental | An 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). Acoustic simulations will be performed with the k-Wave Matlab Toolbox to individually confirm the estimated total energy delivered during sonication and verify tissue temperature increases are <1°C, decreasing actual Power/Channel values if necessary. We estimate a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore we 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 derated ISPPA). Receives: Other: Low-intensity focused ultrasound |
| Sham LIFU | Sham comparator | Identical parameters of sonication and positioning procedures as those in the Active LIFU arm will be employed, but a Sorbothane(R) film will be interposed between the transducer and the subject's scalp. 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 Change in the Intensity of Repetitive Negative Thinking
Change of BSRI (Brief State Rumination Inventory) score; minimum value: 0, maximum value: 800; higher scores mean worse outcome.
Measured: Pre- vs 10-minute post-sonication or sham intervention.
Secondary outcomes (1)
Suicide Safety Indicators
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) score, minimum value: 0; maximum value: 25; higher scores mean worse outcome.
Measured: Pre- vs 1-hour and 1-week post-sonication or sham intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start15 Dec 2022
- Primary completion6 Feb 2024
- Study completion6 Feb 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 DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An exploratory hypothesis is that stimulation of anteromedial structures of the telencephalic cortex of the right hemisphere and their connections with subcortical structures will lead to detectable attenuation of RNT in high RNT depressed individuals. In this study, the investigators will use a double-blind, randomized cross-over design employing either tfUS or sham stimulation. The proposed design parsimoniously follows the approved pilot study supported by the Center of Biomedical Research Excellence grant NeuroMAP (P20GM121312), in which the investigators will characterize neural circuits associated to RNT.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
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
- NCT05697172
- Sponsor's protocol ID
- 2021-011
- Status last verified
- Aug 2024
- First submitted
- 11 Nov 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsuchiyagaito A, Kuplicki R, Misaki M, Edwards L, Camprodon JA, Fitzgerald K, Khalsa SS, Philip NS, Paulus MP, Guinjoan SM. Reversible modulation of a deep white matter surgical target for depression with low-intensity focused ultrasound. Neuropsychopharmacology. 2026 Feb;51(3):612-621. doi: 10.1038/s41386-025-02252-7. Epub 2025 Sep 25.
PubMed 40999237
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Circuits Underlying Repetitive Negative and Self-Referential Thinking in Depression: An Early Feasibility Study Employing Transcranial Focused Ultrasound
- ClinicalTrials.gov ID
- NCT05697172
- Acronym / sponsor ID
- 2021-011
- Conditions
- Major Depressive Disorder
- Keywords
- Repetitive Negative Thinking, Low-Intensity Focused Ultrasound, Major Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 25 Jan 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.
The investigators propose to use low-intensity transcranial focused ultrasound (LIFU), a novel neuromodulation method, to probe the causal involvement of individually defined components of an anteromedial brain circuit in the processing of self-referential thoughts, and the production of repetitive negative thinking (RNT), a prominent transdiagnostic manifestation with adverse clinical consequences. The investigators hypothesize that real vs. sham low-intensity sonication of individually-defined anteromedial structures connecting medial orbitofrontal and anterior cingulate cortices with ventral striatum and anterior thalamus will show reduced initiation or maintenance of RNT as measured by (1) Brief State Rumination Inventory (BSRI) scores and distress associated to repetitive negative thoughts, and (2) improvement of the affective valence associated to self-referential adjectives, and that these changes will be associated with decreased connectivity between structures mentioned above. The present early feasibility study is an initial step that aims to determine its feasibility and help with the planning of a larger study addressed at actual hypothesis testing.
Detailed description
Depression represents a remarkable public health burden, accounting for a large amount of disability and societal costs, comparable to prevalent diseases in other areas of medicine. This is partly due to unsatisfactory outcomes of well-established therapies, including psychotropic drugs and different types of psychotherapy. As a response to this problem, therapeutics in psychiatry is moving from drug manipulation of neurotransmitter systems to modulation of brain circuits selectively involved in specific symptoms of depression. These efforts have been partially hampered, however, by heterogeneity of clinical manifestations in these disorders, such that different symptoms are hypothesized to be maintained by specific circuit-level dysfunctions, as well as by significant interindividual variation in those brain circuits, which calls for personalized approaches to achieve their successful modulation. Thus far, the efforts to accomplish individualized and precise modulation of aberrant circuits responsible for the expression of depression and anxiety symptoms have encountered three important, mutually related problems. First, widely available noninvasive neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have poor spatial resolution and only reach superficial areas of the brain, which impedes the precise modulation of circuits that involve deep, minute subcortical gray matter structures and/or white matter connecting tracts. Second, surgical deep-brain stimulation procedures are more accurate but are too costly and risky to be implemented in any moderately sized proof-of-concept study at present. Third, it is unlikely that modification of the activity of a discrete brain circuit will target the entire complex behavioral macro of major depression. The investigators therefore chose to target a single measurable and replicable construct of depression, repetitive negative thinking (RNT). RNT is a transdiagnostic clinical manifestation that cuts across a variety of internalizing psychiatric disorders, but in the case of depression, it is associated with persistent symptoms, treatment resistance, proneness to relapse after treatment, and more suicidal ideation, behavior, and completed suicides. With the help of an emerging technology device recently acquired by LIBR, which can produce focused, reversible and noninvasive neuromodulation in deep brain structures (low-intensity transcranial focused ultrasound, tfUS), the investigators will probe the causal role of individually-identified circuits in the modulation of (a) the generation and maintenance of repetitive negative thinking (RNT), and (b) affective processing of self-referential adjectives. Specifically, the investigators will put to test the hypotheses that RNT and the affective load of self-referential adjectives can be improved by modulating components of an anteromedial brain circuit, identified on an individual basis as associated with high levels of RNT. Therefore, this project has two distinct phases. First, the investigators will use advanced structural-functional connectivity analysis techniques to define anatomical tracts that support functional connectivity alterations associated with high RNT. The investigators will refine and adjust results of whole-brain analyses, by focusing also on overlapping anatomical components of tracts pertaining to three well-established, historical psychosurgical targets of antidepressant and obsessional thinking treatment. Second, the investigators will employ the resulting regions of interest to inform the choice of the target(s) for tfUS neuromodulation, probing its effects on 1) neural processing of self-referential affective adjectives, 2) functional connectivity between regions known to have an anatomical connection in the individual participant, and 3) measures of RNT and clinical depression, including the degree of distress associated to the thought/s subjected to RNT. The investigators are in an ideal position to accomplish these objectives, given their experience with clinical management of these disorders, with the use of neuromodulation techniques, and expertise in the use of state-of-the-art structural and functional neuroimaging techniques, psychophysiological tools, and computational psychiatry methods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- An exploratory hypothesis is that stimulation of anteromedial structures of the telencephalic cortex of the right hemisphere and their connections with subcortical structures will lead to detectable attenuation of RNT in high RNT depressed individuals. In this study, the investigators will use a double-blind, randomized cross-over design employing either tfUS or sham stimulation. The proposed design parsimoniously follows the approved pilot study supported by the Center of Biomedical Research Excellence grant NeuroMAP (P20GM121312), in which the investigators will characterize neural circuits associated to RNT.
| Arm | Type | Receives |
|---|---|---|
| Active Low Intensity Focused Ultrasound (LIFU) | Experimental | Other: Low-intensity focused ultrasoundAn 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). Acoustic simulations will be performed with the k-Wave Matlab Toolbox to individually confirm the estimated total energy delivered during sonication and verify tissue temperature increases are <1°C, decreasing actual Power/Channel values if necessary. We estimate a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore we 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 derated ISPPA). |
| Sham LIFU | Sham comparator | Other: Low-intensity focused ultrasoundIdentical parameters of sonication and positioning procedures as those in the Active LIFU arm will be employed, but a Sorbothane(R) film will be interposed between the transducer and the subject's scalp. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Prior participation in the CoBRE study (WIRB Protocol #20182352) and selected as a component of the propensity-matched sample of patients with major depression and varying intensities of RNT (in the form of Ruminative Response Scale (RRS) score; n=20), or healthy individuals with no psychiatric diagnosis (n=10), OR In the unexpected event that not enough participants can be recruited who meet criterion 1 (only 1 out of 6 studied patients would be incorporated into this study), participants will be newly recruited from newly recruited patients from the community or from the Mood and Anxiety Disorders inpatient unit at Laureate Psychiatric Hospital and Clinic.
- A Patient Health Questionnaire (PHQ-9) score ≥ 10 at enrollment.
- Provision of signed and dated informed consent form.
- Subject provides verifiable contact information (name, telephone number(s), email and mailing address) for at least 2 persons who agree to be contacted by study personnel as deemed necessary.
- Subject is followed by a licensed physician or a licensed mental health care provider (i.e., psychologist, LCSW) throughout study participation outside of LIBR.
Key exclusion criteria (9 listed)
- Current use (within the last 30 days) of drugs of abuse or moderate / severe alcohol use disorder.
- Lifetime diagnosis of schizophrenia spectrum disorder, other nonaffective psychotic disorders, or bipolar disorders.
- Presence of cardiac pacemaker or any other MRI contraindication.
- Pregnancy or lactation.
- Febrile illness within the last two weeks.
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 | Active Low Intensity Focused Ultrasound (LIFU), Sham LIFU |
Primary outcome
Post-Sonication Change in the Intensity of Repetitive Negative Thinking
Time frame: Pre- vs 10-minute post-sonication or sham intervention.
Change of BSRI (Brief State Rumination Inventory) score; minimum value: 0, maximum value: 800; higher scores mean worse outcome.
1 secondary outcome
Suicide Safety Indicators
Time frame: Pre- vs 1-hour and 1-week post-sonication or sham intervention.
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 5 Aug 2024.
- Derived from this study: PubMed 40999237Tsuchiyagaito A, Kuplicki R, Misaki M, Edwards L, Camprodon JA, Fitzgerald K, Khalsa SS, Philip NS, Paulus MP, Guinjoan SM. Reversible modulation of a deep white matter surgical target for depression with low-intensity focused ultrasound. Neuropsychopharmacology. 2026 Feb;51(3):612-621. doi: 10.1038/s41386-025-02252-7. Epub 2025 Sep 25.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Major Depressive Disorder, 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 10 inclusion and 9 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 5 Aug 2024. 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?
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?
Post-Sonication Change in the Intensity of Repetitive Negative Thinking (time frame: Pre- vs 10-minute post-sonication or sham intervention.). 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 NCT05697172, 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 5 Aug 2024.