Traumatic Brain InjuryNCT06070025
Impact of Pre-Military Life Experiences/Exposures on Active-Duty Service Members' Psychological Health
An observational study of Traumatic Brain Injury, run by University of Southern California at 1 site in United States.
Trial summary
The goal of this observational study is to learn about the impact of historic and current Traumatic Brain Injuries on a Marine Battalion. Its main objectives are: Establish individual mental and physical performance profile and brain health baseline in Infantry Marines Develop predictive models to identify early signs… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2023to 30 Apr 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy service members of the 1st Marine Division 1st Battalion out of Camp Pendleton, CA
Who may be able to join
- Members of the 1st Marine Division 1st Battalion
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pre-Military Life Experiences/Exposures on Active-Duty Service Members' Psychological Health and Adjustment Over a Marine Battalion Deployment Cycle
The goal of this observational study is to learn about the impact of historic and current Traumatic Brain Injuries on a Marine Battalion. Its main objectives are:
- Establish individual mental and physical performance profile and brain health baseline in Infantry Marines
- Develop predictive models to identify early signs of mental and/or physical degradation that can help predict "red-line" behavioral events and degradation in brain health.
- Gather insights that will lead to developing personalized, evidence-based interventions to restore mental and physical performance.
- Increase warfighter self-knowledge and personal awareness to monitor and maximize performance.
Participants will wear wear smart watches and analyte sensors to track their real time physiological and sleep measures and complete subjective and psychological measures in a custom research app.
Read the detailed description
To prevent brain health degradation, it is necessary to understand the factors that contribute to brain insult and injury. The investigators aim to understand and identify pre-exposure risk, reversible and irreversible injury, and the impact of stressors. The investigators will research the real-time interaction between exposure and injury biomarkers and identify how the interaction affects long-term health and measures such as time to recovery.
The project will work with a newly formed Infantry Marine Battalion on Camp Pendleton. This group of Service Members will have many that are beginning their military careers, and thus will bring in only the components of brain health and emotional trauma they have accumulated during their civilian lives to this point.
Participants will be provided with a customized research mobile application that will obtain baseline information related to their military history and experience, and then continuously track activity, physiologic parameters, sleep, cognition and emotional state. Detailed dietary consumption and metabolic data, if indicated, will be tracked and displayed. The data will be collected continuously
During the study, participants will be provided with their data in real-time and this will be displayed along with their schedule and tasks. During and upon completion of the study investigators will provide a detailed summary and analysis of their health and human performance metrics, including insights on how diet and activity impacts their metabolic control or other biomarkers and how all of these factors impact sleep, cognition and behavioral state. The investigators will collaborate with the participants to identify the most useful data displays and information that will best help them achieve optimized physical, mental and cognitive training and recovery and gain understanding of how metabolic control or other biomarkers impact these metrics.
These insights will be used to develop insight dashboards on the holistic health metrics mentioned above, and help provide optimization insights. We will work with participants to create additional app content specific for them that relates to optimal diet and mental and physical training and recovery.
- Conditions
- Traumatic Brain Injury
- Keywords
- brain health, traumatic brain injury, marines, wearables, physiological sensors
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Explanation of Outcomes
In a traditional clinical trial, we would have explicitly included measures, or measurement tool used to assess the measure, along with the measurement units that would be used to assess this outcome measure.
However, in this novel prospective digital health trial, these outcomes are not predefined, but are part of discovery within the digital app. Therefore these data will be reported as digital biomarkers that will not necessarily conform with the typical single or multi-variable traditional clinical trial and will include many novel measurement parameters and blended measures.
For instance, a novel measurement that will be used to assess the effect of engaging in this clinical trial will be app adherence, which is not a variable generally used in clinical trials.
Measured: 18 months
Establish individual mental and physical performance profile and brain health baseline in Infantry Marines.
Establish individual mental and physical performance profile and brain health baseline in Infantry Marines from physiological and psychological assessments. Assessments will be scored and recorded to contrast with scores during the study and at its conclusion for individuals as well as the group. Scores will be used to determine correlates and other connections between variables. This will include such connections as the connection between TBI history and current cognitive and psychological assessments, etc.
Measured: 1 month
Develop predictive models
Develop predictive models to identify early signs of mental and/or physical degradation that can help predict adverse brain health or behavioral events using continuous physiological data and ongoing cognitive and psychological measures. Using assessments on baseline cognitive, physiological and psychological states combined with continuous and periodic assessments of these states, changes in TBI status and cognitive status will be correlated with biomarkers such as sleep, heart rate, O2 measures, glucose measures, and others (as described elsewhere) in order to discover new indications for adverse brain health.
Measured: 18 months
Increase warfighter self-knowledge and personal awareness
Determine warfighter self-knowledge and personal awareness by developing and measuring self-reported and recorded interaction with personalized educational and interventional portions of the research app. Because we are interested in individuals being invested in their own data in order to make behavioral changes, we will establish baseline assessment scores, and deliver them back to the user with explanations. Participants will also receive continuous biomarker data. This will allow participants to decide if they will make any changes in their behavior or seek help in order to improve their own health outcomes. These will be measured in the same ways as described earlier - changes in sleep patterns, changes in eating habits, changes in drinking habits, etc., as well as level of access by participants of insights and other tools in the research app.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start22 Jan 2023
- Primary completion31 Dec 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Saxon, MD, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070025
- Sponsor's protocol ID
- Brain Health Marine Btln
- Other IDs
- W81XWH-22-1-0956
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beckner ME, Main L, Tait JL, Martin BJ, Conkright WR, Nindl BC. Circulating biomarkers associated with performance and resilience during military operational stress. Eur J Sport Sci. 2022 Jan;22(1):72-86. doi: 10.1080/17461391.2021.1962983. Epub 2021 Aug 17.
PubMed 34346851Bollyky JB, Bravata D, Yang J, Williamson M, Schneider J. Remote Lifestyle Coaching Plus a Connected Glucose Meter with Certified Diabetes Educator Support Improves Glucose and Weight Loss for People with Type 2 Diabetes. J Diabetes Res. 2018 May 16;2018:3961730. doi: 10.1155/2018/3961730. eCollection 2018.
PubMed 29888288Brynes AE, Adamson J, Dornhorst A, Frost GS. The beneficial effect of a diet with low glycaemic index on 24 h glucose profiles in healthy young people as assessed by continuous glucose monitoring. Br J Nutr. 2005 Feb;93(2):179-82. doi: 10.1079/bjn20041318.
PubMed 15788110Cauza E, Hanusch-Enserer U, Strasser B, Kostner K, Dunky A, Haber P. Strength and endurance training lead to different post exercise glucose profiles in diabetic participants using a continuous subcutaneous glucose monitoring system. Eur J Clin Invest. 2005 Dec;35(12):745-51. doi: 10.1111/j.1365-2362.2005.01573.x.
PubMed 16313250Eslam M, Sarin SK, Wong VW, Fan JG, Kawaguchi T, Ahn SH, Zheng MH, Shiha G, Yilmaz Y, Gani R, Alam S, Dan YY, Kao JH, Hamid S, Cua IH, Chan WK, Payawal D, Tan SS, Tanwandee T, Adams LA, Kumar M, Omata M, George J. The Asian Pacific Association for the Study of the Liver clinical practice guidelines for the diagnosis and management of metabolic associated fatty liver disease. Hepatol Int. 2020 Dec;14(6):889-919. doi: 10.1007/s12072-020-10094-2. Epub 2020 Oct 1.
PubMed 33006093Freckmann G, Hagenlocher S, Baumstark A, Jendrike N, Gillen RC, Rossner K, Haug C. Continuous glucose profiles in healthy subjects under everyday life conditions and after different meals. J Diabetes Sci Technol. 2007 Sep;1(5):695-703. doi: 10.1177/193229680700100513.
PubMed 19885137Gambhir SS, Ge TJ, Vermesh O, Spitler R, Gold GE. Continuous health monitoring: An opportunity for precision health. Sci Transl Med. 2021 Jun 9;13(597):eabe5383. doi: 10.1126/scitranslmed.abe5383.
PubMed 34108250Garcia-Compean D, Jaquez-Quintana JO, Gonzalez-Gonzalez JA, Lavalle-Gonzalez FJ, Villarreal-Perez JZ, Maldonado-Garza HJ. [Diabetes in liver cirrhosis]. Gastroenterol Hepatol. 2013 Aug-Sep;36(7):473-82. doi: 10.1016/j.gastrohep.2013.01.012. Epub 2013 Apr 28. Spanish.
PubMed 23628170FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Available from http://www.ncbi.nlm.nih.gov/books/NBK326791/
PubMed 27010052Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, Snyder M. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul 24;16(7):e2005143. doi: 10.1371/journal.pbio.2005143. eCollection 2018 Jul.
PubMed 30040822Hamaguchi E, Takamura T, Sakurai M, Mizukoshi E, Zen Y, Takeshita Y, Kurita S, Arai K, Yamashita T, Sasaki M, Nakanuma Y, Kaneko S. Histological course of nonalcoholic fatty liver disease in Japanese patients: tight glycemic control, rather than weight reduction, ameliorates liver fibrosis. Diabetes Care. 2010 Feb;33(2):284-6. doi: 10.2337/dc09-0148. Epub 2009 Oct 30.
PubMed 19880582Hazell TJ, Islam H, Townsend LK, Schmale MS, Copeland JL. Effects of exercise intensity on plasma concentrations of appetite-regulating hormones: Potential mechanisms. Appetite. 2016 Mar 1;98:80-8. doi: 10.1016/j.appet.2015.12.016. Epub 2015 Dec 22.
PubMed 26721721Holzer R, Bloch W, Brinkmann C. Continuous Glucose Monitoring in Healthy Adults-Possible Applications in Health Care, Wellness, and Sports. Sensors (Basel). 2022 Mar 5;22(5):2030. doi: 10.3390/s22052030.
PubMed 35271177Jacobs I. Blood lactate. Implications for training and sports performance. Sports Med. 1986 Jan-Feb;3(1):10-25. doi: 10.2165/00007256-198603010-00003.
PubMed 2868515Kim CH, Younossi ZM. Nonalcoholic fatty liver disease: a manifestation of the metabolic syndrome. Cleve Clin J Med. 2008 Oct;75(10):721-8. doi: 10.3949/ccjm.75.10.721.
PubMed 18939388
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-Military Life Experiences/Exposures on Active-Duty Service Members' Psychological Health and Adjustment Over a Marine Battalion Deployment Cycle
- ClinicalTrials.gov ID
- NCT06070025
- Acronym / sponsor ID
- Brain Health Marine Btln
- Conditions
- Traumatic Brain Injury
- Keywords
- brain health, traumatic brain injury, marines, wearables, physiological sensors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 6 Oct 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 goal of this observational study is to learn about the impact of historic and current Traumatic Brain Injuries on a Marine Battalion. Its main objectives are:
- Establish individual mental and physical performance profile and brain health baseline in Infantry Marines
- Develop predictive models to identify early signs of mental and/or physical degradation that can help predict "red-line" behavioral events and degradation in brain health.
- Gather insights that will lead to developing personalized, evidence-based interventions to restore mental and physical performance.
- Increase warfighter self-knowledge and personal awareness to monitor and maximize performance.
Participants will wear wear smart watches and analyte sensors to track their real time physiological and sleep measures and complete subjective and psychological measures in a custom research app.
Detailed description
To prevent brain health degradation, it is necessary to understand the factors that contribute to brain insult and injury. The investigators aim to understand and identify pre-exposure risk, reversible and irreversible injury, and the impact of stressors. The investigators will research the real-time interaction between exposure and injury biomarkers and identify how the interaction affects long-term health and measures such as time to recovery.
The project will work with a newly formed Infantry Marine Battalion on Camp Pendleton. This group of Service Members will have many that are beginning their military careers, and thus will bring in only the components of brain health and emotional trauma they have accumulated during their civilian lives to this point.
Participants will be provided with a customized research mobile application that will obtain baseline information related to their military history and experience, and then continuously track activity, physiologic parameters, sleep, cognition and emotional state. Detailed dietary consumption and metabolic data, if indicated, will be tracked and displayed. The data will be collected continuously
During the study, participants will be provided with their data in real-time and this will be displayed along with their schedule and tasks. During and upon completion of the study investigators will provide a detailed summary and analysis of their health and human performance metrics, including insights on how diet and activity impacts their metabolic control or other biomarkers and how all of these factors impact sleep, cognition and behavioral state. The investigators will collaborate with the participants to identify the most useful data displays and information that will best help them achieve optimized physical, mental and cognitive training and recovery and gain understanding of how metabolic control or other biomarkers impact these metrics.
These insights will be used to develop insight dashboards on the holistic health metrics mentioned above, and help provide optimization insights. We will work with participants to create additional app content specific for them that relates to optimal diet and mental and physical training and recovery.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy service members of the 1st Marine Division 1st Battalion out of Camp Pendleton, CA
Key inclusion criteria (1 listed)
- Members of the 1st Marine Division 1st Battalion
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Explanation of Outcomes
Time frame: 18 months
In a traditional clinical trial, we would have explicitly included measures, or measurement tool used to assess the measure, along with the measurement units that would be used to assess this outcome measure. However, in this novel prospective digital health trial, these outcomes are not predefined, but are part of discovery within the digital app. Therefore these data will be reported as digital biomarkers that will not necessarily conform with the typical single or multi-variable traditional clinical trial and will include many novel measurement parameters and blended measures. For instance, a novel measurement that will be used to assess the effect of engaging in this clinical trial will be app adherence, which is not a variable generally used in clinical trials.
Establish individual mental and physical performance profile and brain health baseline in Infantry Marines.
Time frame: 1 month
Establish individual mental and physical performance profile and brain health baseline in Infantry Marines from physiological and psychological assessments. Assessments will be scored and recorded to contrast with scores during the study and at its conclusion for individuals as well as the group. Scores will be used to determine correlates and other connections between variables. This will include such connections as the connection between TBI history and current cognitive and psychological assessments, etc.
Develop predictive models
Time frame: 18 months
Develop predictive models to identify early signs of mental and/or physical degradation that can help predict adverse brain health or behavioral events using continuous physiological data and ongoing cognitive and psychological measures. Using assessments on baseline cognitive, physiological and psychological states combined with continuous and periodic assessments of these states, changes in TBI status and cognitive status will be correlated with biomarkers such as sleep, heart rate, O2 measures, glucose measures, and others (as described elsewhere) in order to discover new indications for adverse brain health.
Increase warfighter self-knowledge and personal awareness
Time frame: 18 months
Determine warfighter self-knowledge and personal awareness by developing and measuring self-reported and recorded interaction with personalized educational and interventional portions of the research app. Because we are interested in individuals being invested in their own data in order to make behavioral changes, we will establish baseline assessment scores, and deliver them back to the user with explanations. Participants will also receive continuous biomarker data. This will allow participants to decide if they will make any changes in their behavior or seek help in order to improve their own health outcomes. These will be measured in the same ways as described earlier - changes in sleep patterns, changes in eating habits, changes in drinking habits, etc., as well as level of access by participants of insights and other tools in the research app.
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 24 Aug 2026.
- Background: PubMed 34346851Beckner ME, Main L, Tait JL, Martin BJ, Conkright WR, Nindl BC. Circulating biomarkers associated with performance and resilience during military operational stress. Eur J Sport Sci. 2022 Jan;22(1):72-86. doi: 10.1080/17461391.2021.1962983. Epub 2021 Aug 17.
- Background: PubMed 29888288Bollyky JB, Bravata D, Yang J, Williamson M, Schneider J. Remote Lifestyle Coaching Plus a Connected Glucose Meter with Certified Diabetes Educator Support Improves Glucose and Weight Loss for People with Type 2 Diabetes. J Diabetes Res. 2018 May 16;2018:3961730. doi: 10.1155/2018/3961730. eCollection 2018.
- Background: PubMed 15788110Brynes AE, Adamson J, Dornhorst A, Frost GS. The beneficial effect of a diet with low glycaemic index on 24 h glucose profiles in healthy young people as assessed by continuous glucose monitoring. Br J Nutr. 2005 Feb;93(2):179-82. doi: 10.1079/bjn20041318.
- Background: PubMed 16313250Cauza E, Hanusch-Enserer U, Strasser B, Kostner K, Dunky A, Haber P. Strength and endurance training lead to different post exercise glucose profiles in diabetic participants using a continuous subcutaneous glucose monitoring system. Eur J Clin Invest. 2005 Dec;35(12):745-51. doi: 10.1111/j.1365-2362.2005.01573.x.
- Background: PubMed 33006093Eslam M, Sarin SK, Wong VW, Fan JG, Kawaguchi T, Ahn SH, Zheng MH, Shiha G, Yilmaz Y, Gani R, Alam S, Dan YY, Kao JH, Hamid S, Cua IH, Chan WK, Payawal D, Tan SS, Tanwandee T, Adams LA, Kumar M, Omata M, George J. The Asian Pacific Association for the Study of the Liver clinical practice guidelines for the diagnosis and management of metabolic associated fatty liver disease. Hepatol Int. 2020 Dec;14(6):889-919. doi: 10.1007/s12072-020-10094-2. Epub 2020 Oct 1.
- Background: PubMed 19885137Freckmann G, Hagenlocher S, Baumstark A, Jendrike N, Gillen RC, Rossner K, Haug C. Continuous glucose profiles in healthy subjects under everyday life conditions and after different meals. J Diabetes Sci Technol. 2007 Sep;1(5):695-703. doi: 10.1177/193229680700100513.
- Background: PubMed 34108250Gambhir SS, Ge TJ, Vermesh O, Spitler R, Gold GE. Continuous health monitoring: An opportunity for precision health. Sci Transl Med. 2021 Jun 9;13(597):eabe5383. doi: 10.1126/scitranslmed.abe5383.
- Background: PubMed 23628170Garcia-Compean D, Jaquez-Quintana JO, Gonzalez-Gonzalez JA, Lavalle-Gonzalez FJ, Villarreal-Perez JZ, Maldonado-Garza HJ. [Diabetes in liver cirrhosis]. Gastroenterol Hepatol. 2013 Aug-Sep;36(7):473-82. doi: 10.1016/j.gastrohep.2013.01.012. Epub 2013 Apr 28. Spanish.
- Background: PubMed 27010052FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Available from http://www.ncbi.nlm.nih.gov/books/NBK326791/
- Background: PubMed 30040822Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, Snyder M. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul 24;16(7):e2005143. doi: 10.1371/journal.pbio.2005143. eCollection 2018 Jul.
- Background: PubMed 19880582Hamaguchi E, Takamura T, Sakurai M, Mizukoshi E, Zen Y, Takeshita Y, Kurita S, Arai K, Yamashita T, Sasaki M, Nakanuma Y, Kaneko S. Histological course of nonalcoholic fatty liver disease in Japanese patients: tight glycemic control, rather than weight reduction, ameliorates liver fibrosis. Diabetes Care. 2010 Feb;33(2):284-6. doi: 10.2337/dc09-0148. Epub 2009 Oct 30.
- Background: PubMed 26721721Hazell TJ, Islam H, Townsend LK, Schmale MS, Copeland JL. Effects of exercise intensity on plasma concentrations of appetite-regulating hormones: Potential mechanisms. Appetite. 2016 Mar 1;98:80-8. doi: 10.1016/j.appet.2015.12.016. Epub 2015 Dec 22.
- 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?
An observational study of Traumatic Brain Injury, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 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 24 Aug 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?
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?
Explanation of Outcomes (time frame: 18 months). 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 NCT06070025, which also lists 34 linked publications.
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 24 Aug 2026.