Traumatic Brain Injury (TBI)NCT02504866
Effect of Exercise Training on Physical, Cognitive, and Behavioral Function in People With TBI
A study testing Vigorous exercise and Light to moderate exercise in people with Traumatic Brain Injury (TBI), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Traumatic brain injury (TBI) often causes problems with moving and balance, and thinking and emotions. Exercise can improve these things in people with other brain damage. Researchers want to look at the effect of exercise on these things in people with TBI. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury (TBI)
- What is being tested?
- Vigorous exercise and Light to moderate exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2016to 6 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 to 79 inclusive
- Diagnosis of non-penetrating TBI
- Injury occurred at least 12 months prior to enrollment
- Physically inactive as identified by a physician
- Able to stand and walk independently and safely without any assistance
- Able to follow the study protocol
Show all 10Show fewer
- Fluent in English and able to provide informed consent
- Ages 18 to 79 inclusive
- Physically inactive as identified by a physician
- Fluent in English
Who cannot join
- History of exercise intolerance
- History of heart disease
- History of pulmonary disease, other than controlled, non-exercise-induced asthma
- History of uncontrolled diabetes
- Uncontrolled hypertension, defined as a resting blood pressure > 140/90 mmHg
- On medications that would influence aerobic capacity or treadmill performance such as beta blockers or antiretroviral therapy
Show all 25Show fewer
- Active substance abuse including ETOH
- Presence of an injury to any extremity, or other medical condition that would affect motor function or the ability to perform the assessment or the exercise program, specifically balance problems due to vestibulopathy
- Unable to refrain from smoking at least 4 hours prior to exercise testing sessions
- Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
- Pregnancy
- BMI >40 kg/M(2) due to the limits of the treadmill, elliptical machine and MRI scanner
- Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function
- Have any of the following contraindications to having an MRI scan:
- A ventriculo-peritoneal shunt
- Have claustrophobia and not comfortable in small enclosed spaces
- Have metal that would make an MRI scan unsafe such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion devise, cochlear or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing that cannot be removed, bone or joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal embedded (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near your eyes).
- Excessive startle reaction to or fear of loud noises
- History or presence of cardiopulmonary or respiratory disease
- History or presence of other disease of the neurologic, metabolic, or renal systems
- Active substance abuse including ETOH
- Pregnancy
- BMI >40 kg/m2
- Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
- Have any contraindications to having an MRI scan
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Effect of Exercise Training on Physical, Cognitive and Behavioral Function in Patients With Traumatic Brain Injury
Background:
- Traumatic brain injury (TBI) often causes problems with moving and balance, and thinking and emotions. Exercise can improve these things in people with other brain damage. Researchers want to look at the effect of exercise on these things in people with TBI.
Read more
Objectives:
- To study how head injuries affect the brain. To study if exercise can help some symptoms in people with TBI. These include problems thinking, balancing, and moving, and depression or anxiety.
Eligibility:
- People age between 18 and 79
- Had a non-penetrating TBI at least 12 months ago
- Are physically inactive, but can stand and walk without help
Design:
- Participants will be screened with medical history, physical exam, and blood and urine tests. They may have a balance test.
- Participants will be assigned to a high-intensity or a lower-intensity exercise program.
- The study is 6 months long. There will be 3 months with exercise on an elliptical machine and 3 months without exercise.
- Participants will exercise for 30 minutes on an elliptical machine, 3 days per week for 3 months.
- Participants will also have 3 outpatient testing visits lasting approximately 8 hours, once every 3 months. This visit will include:
- Blood tests
- Tests for memory, attention, and thinking
- Tests of walking and balance
- Questionnaires
- An MRI: they will lie in a machine that takes pictures of their brain, while breathing regular air and air with more carbon dioxide
- Test of physical fitness
Read the detailed description
Objective
The broad objective of this study is to examine the effects of moderate and more intense aerobic exercise as an intervention on cognitive performance, physical functioning and health-related quality of life in patients with chronic (more than 12 months post-injury) traumatic brain injury (TBI). Importantly, structural and biological brain changes will be measured to examine whether functional outcomes are related to exercise-induced adaptations. It is hypothesized that in the chronic phase of persons with TBI, there will be improved: 1) cognitive function, 2) physical fitness and fatigue severity, 3) motor performance and balance, and 4) mood and depressive symptoms, in those that performed the exercise intervention compared to a control group. It is also hypothesized that these functional improvements will be related to exercise intensity, improved cortical connectivity, dopamine transmission gene scores, and blood biomarkers related to neuro and angio-genesis.
Study Population
80 ambulatory adults with non-penetrating TBI will be enrolled. We will also enroll up to 20 healthy volunteers as a comparison group for some of the outcome measures. Subjects will be recruited from NIH, affiliated hospitals/clinics and the community
Design
Healthy volunteers will have a limited assessment that includes brain imaging, blood draw for genetic testing, and a subset of the cognitive and behavioral testing at a single time-point. All subjects with TBI will perform baseline assessments including cognitive and behavioral performance, brain imaging, fitness, motor and balance testing, and selected blood and genetic testing. Thereafter, subjects with TBI will be randomized to either a waitlist control, or one of two exercise conditions: 1) 30 minutes at a fast pace, moderate-intensity (rapid-resistive exercise; RET); 2) 30 minutes at higher-intensity (aerobic exercise; AET). Both exercise groups will perform the exercise on an elliptical trainer 3 times a week, for a session duration of 45 minutes including warm-up and cool-down. The RET group will focus on rapid reciprocal motion with minimal resistance, while the AET group will exercise at an elevated intensity known to produce an aerobic effect. After 12 weeks, all groups will repeat the baseline assessments (3 month follow-up). Following this assessment, the waitlist control group will be randomized to either RET or AET and the exercise groups will cease formal supervised exercise sessions. A third assessment visit will be performed after an additional 12 weeks (6 month follow-up).
Outcome Measures
Cognitive performance will be tested and interpreted compared to norms. Performance on motor and balance tasks will be assessed with the Smart Balance Measurement System and the GAITRite System. Physical fitness will be determined by peak oxygen consumption and aerobic threshold as measured by pulmonary gas exchange during an exercise tolerance test on the treadmill. Structural brain volumes will be determined by magnetic resonance imaging (MRI) and cortical connectivity will be quantified using resting state functional MRI and Diffusion Tensor Imaging (DTI) to evaluate integrity of and changes in white matter tracts in response to exercise and compared to healthy volunteers. Blood will be collected to quantify the presence of biomarkers (such as VEGF, BDNF and IGF-1) and dopamine transmission. Other self-reported measures of quality of life, fatigue severity, depression and sleep quality would also be collected, and compared to healthy volunteers.
- Conditions
- Traumatic Brain Injury (TBI)
- Being tested
- Vigorous exercise, Light to moderate exercise
- Keywords
- Aerobic Exercise Training, Balance, TBI, Rapid-Resistive Exercise
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigorous exerciseOther
Exercise training of vigorous intensity
Light to moderate exerciseOther
Exercise training of light to moderate intensity
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Intervention (AET) | Experimental | Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks Receives: Other: Vigorous exercise |
| Rapid-Resistive Exercise Intervention (RET) | Experimental | Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks Receives: Other: Light to moderate exercise |
| Waitlist Control (CON) | No intervention | Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks. They were randomized to either AET or RET after the initial 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function as Measured by Trail Making Test Part B (TMT-B)
Trail Making Test (TMT) is a neuropsychological assessment of visual conceptual and visual motor tracking (involves motor speed and attention functions). Trail Making Test Part B (TMT-B) is associated with executive functioning and involves drawing a line connecting alternating numbers and letters in sequence (i.e., 1-A-2-B and so on). The time to complete the test is recorded. The time taken to complete the test was converted into standardized T-scores, representing a mean of 50 and a standard deviation of 10. Higher T-scores mean less cognitive deficits. The change in cognitive function was reported as the change in TMT-B T-scores across the 12 weeks (post minus pre intervention).
Measured: Before (pre) and after (post) 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study start15 Dec 2016
- Primary completion4 Feb 2020
- Study completion6 Feb 2020
Why it stopped: Study was terminated early due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (TBI)Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM)
- Responsible party
- Sponsor
- Investigators
- Diane L Damiano, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504866
- Sponsor's protocol ID
- 150164
- Other IDs
- 15-CC-0164
- Status last verified
- Feb 2023
- First submitted
- 21 Jul 2015
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data and samples will be stored in the Center for Neuroscience and Regenerative Medicine (CNRM) data and biospecimen repositories, respectively. Data uploaded to the CNRM repository will be made available to other CNRM researchers upon request.
Publications
Chin LM, Keyser RE, Dsurney J, Chan L. Improved cognitive performance following aerobic exercise training in people with traumatic brain injury. Arch Phys Med Rehabil. 2015 Apr;96(4):754-9. doi: 10.1016/j.apmr.2014.11.009. Epub 2014 Nov 26.
PubMed 25433219Chin LM, Chan L, Woolstenhulme JG, Christensen EJ, Shenouda CN, Keyser RE. Improved Cardiorespiratory Fitness With Aerobic Exercise Training in Individuals With Traumatic Brain Injury. J Head Trauma Rehabil. 2015 Nov-Dec;30(6):382-90. doi: 10.1097/HTR.0000000000000062.
PubMed 24901330Damiano DL, Zampieri C, Ge J, Acevedo A, Dsurney J. Effects of a rapid-resisted elliptical training program on motor, cognitive and neurobehavioral functioning in adults with chronic traumatic brain injury. Exp Brain Res. 2016 Aug;234(8):2245-52. doi: 10.1007/s00221-016-4630-8. Epub 2016 Mar 30.
PubMed 27025506
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training on Physical, Cognitive and Behavioral Function in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02504866
- Acronym / sponsor ID
- 150164
- Conditions
- Traumatic Brain Injury (TBI)
- Keywords
- Aerobic Exercise Training, Balance, TBI, Rapid-Resistive Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early due to the COVID-19 pandemic.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM)
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Traumatic brain injury (TBI) often causes problems with moving and balance, and thinking and emotions. Exercise can improve these things in people with other brain damage. Researchers want to look at the effect of exercise on these things in people with TBI.
Objectives:
- To study how head injuries affect the brain. To study if exercise can help some symptoms in people with TBI. These include problems thinking, balancing, and moving, and depression or anxiety.
Eligibility:
- People age between 18 and 79
- Had a non-penetrating TBI at least 12 months ago
- Are physically inactive, but can stand and walk without help
Design:
- Participants will be screened with medical history, physical exam, and blood and urine tests. They may have a balance test.
- Participants will be assigned to a high-intensity or a lower-intensity exercise program.
- The study is 6 months long. There will be 3 months with exercise on an elliptical machine and 3 months without exercise.
- Participants will exercise for 30 minutes on an elliptical machine, 3 days per week for 3 months.
- Participants will also have 3 outpatient testing visits lasting approximately 8 hours, once every 3 months. This visit will include:
- Blood tests
- Tests for memory, attention, and thinking
- Tests of walking and balance
- Questionnaires
- An MRI: they will lie in a machine that takes pictures of their brain, while breathing regular air and air with more carbon dioxide
- Test of physical fitness
Detailed description
Objective
The broad objective of this study is to examine the effects of moderate and more intense aerobic exercise as an intervention on cognitive performance, physical functioning and health-related quality of life in patients with chronic (more than 12 months post-injury) traumatic brain injury (TBI). Importantly, structural and biological brain changes will be measured to examine whether functional outcomes are related to exercise-induced adaptations. It is hypothesized that in the chronic phase of persons with TBI, there will be improved: 1) cognitive function, 2) physical fitness and fatigue severity, 3) motor performance and balance, and 4) mood and depressive symptoms, in those that performed the exercise intervention compared to a control group. It is also hypothesized that these functional improvements will be related to exercise intensity, improved cortical connectivity, dopamine transmission gene scores, and blood biomarkers related to neuro and angio-genesis.
Study Population
80 ambulatory adults with non-penetrating TBI will be enrolled. We will also enroll up to 20 healthy volunteers as a comparison group for some of the outcome measures. Subjects will be recruited from NIH, affiliated hospitals/clinics and the community
Design
Healthy volunteers will have a limited assessment that includes brain imaging, blood draw for genetic testing, and a subset of the cognitive and behavioral testing at a single time-point. All subjects with TBI will perform baseline assessments including cognitive and behavioral performance, brain imaging, fitness, motor and balance testing, and selected blood and genetic testing. Thereafter, subjects with TBI will be randomized to either a waitlist control, or one of two exercise conditions: 1) 30 minutes at a fast pace, moderate-intensity (rapid-resistive exercise; RET); 2) 30 minutes at higher-intensity (aerobic exercise; AET). Both exercise groups will perform the exercise on an elliptical trainer 3 times a week, for a session duration of 45 minutes including warm-up and cool-down. The RET group will focus on rapid reciprocal motion with minimal resistance, while the AET group will exercise at an elevated intensity known to produce an aerobic effect. After 12 weeks, all groups will repeat the baseline assessments (3 month follow-up). Following this assessment, the waitlist control group will be randomized to either RET or AET and the exercise groups will cease formal supervised exercise sessions. A third assessment visit will be performed after an additional 12 weeks (6 month follow-up).
Outcome Measures
Cognitive performance will be tested and interpreted compared to norms. Performance on motor and balance tasks will be assessed with the Smart Balance Measurement System and the GAITRite System. Physical fitness will be determined by peak oxygen consumption and aerobic threshold as measured by pulmonary gas exchange during an exercise tolerance test on the treadmill. Structural brain volumes will be determined by magnetic resonance imaging (MRI) and cortical connectivity will be quantified using resting state functional MRI and Diffusion Tensor Imaging (DTI) to evaluate integrity of and changes in white matter tracts in response to exercise and compared to healthy volunteers. Blood will be collected to quantify the presence of biomarkers (such as VEGF, BDNF and IGF-1) and dopamine transmission. Other self-reported measures of quality of life, fatigue severity, depression and sleep quality would also be collected, and compared to healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Intervention (AET) | Experimental | Other: Vigorous exerciseParticipant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks |
| Rapid-Resistive Exercise Intervention (RET) | Experimental | Other: Light to moderate exerciseParticipant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks |
| Waitlist Control (CON) | No intervention | –Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks. They were randomized to either AET or RET after the initial 12 weeks |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ages 18 to 79 inclusive
- Diagnosis of non-penetrating TBI
- Injury occurred at least 12 months prior to enrollment
- Physically inactive as identified by a physician
- Able to stand and walk independently and safely without any assistance
Key exclusion criteria (25 listed)
- History of exercise intolerance
- History of heart disease
- History of pulmonary disease, other than controlled, non-exercise-induced asthma
- History of uncontrolled diabetes
- Uncontrolled hypertension, defined as a resting blood pressure > 140/90 mmHg
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 |
|---|---|---|
| Vigorous exerciseExercise training of vigorous intensity | Other | Aerobic Exercise Intervention (AET) |
| Light to moderate exerciseExercise training of light to moderate intensity | Other | Rapid-Resistive Exercise Intervention (RET) |
Primary outcome
Change in Cognitive Function as Measured by Trail Making Test Part B (TMT-B)
Time frame: Before (pre) and after (post) 12 weeks intervention
Trail Making Test (TMT) is a neuropsychological assessment of visual conceptual and visual motor tracking (involves motor speed and attention functions). Trail Making Test Part B (TMT-B) is associated with executive functioning and involves drawing a line connecting alternating numbers and letters in sequence (i.e., 1-A-2-B and so on). The time to complete the test is recorded. The time taken to complete the test was converted into standardized T-scores, representing a mean of 50 and a standard deviation of 10. Higher T-scores mean less cognitive deficits. The change in cognitive function was reported as the change in TMT-B T-scores across the 12 weeks (post minus pre intervention).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25433219Chin LM, Keyser RE, Dsurney J, Chan L. Improved cognitive performance following aerobic exercise training in people with traumatic brain injury. Arch Phys Med Rehabil. 2015 Apr;96(4):754-9. doi: 10.1016/j.apmr.2014.11.009. Epub 2014 Nov 26.
- Background: PubMed 24901330Chin LM, Chan L, Woolstenhulme JG, Christensen EJ, Shenouda CN, Keyser RE. Improved Cardiorespiratory Fitness With Aerobic Exercise Training in Individuals With Traumatic Brain Injury. J Head Trauma Rehabil. 2015 Nov-Dec;30(6):382-90. doi: 10.1097/HTR.0000000000000062.
- Background: PubMed 27025506Damiano DL, Zampieri C, Ge J, Acevedo A, Dsurney J. Effects of a rapid-resisted elliptical training program on motor, cognitive and neurobehavioral functioning in adults with chronic traumatic brain injury. Exp Brain Res. 2016 Aug;234(8):2245-52. doi: 10.1007/s00221-016-4630-8. Epub 2016 Mar 30.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data and samples will be stored in the Center for Neuroscience and Regenerative Medicine (CNRM) data and biospecimen repositories, respectively. Data uploaded to the CNRM repository will be made available to other CNRM researchers upon request.
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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.
Diane L Damiano, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigorous exercise and Light to moderate exercise in people with Traumatic Brain Injury (TBI), run by National Institutes of Health Clinical Center (CC) 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 25 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: stopped early, as of the sponsor's last update on 18 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Cognitive Function as Measured by Trail Making Test Part B (TMT-B) (time frame: Before (pre) and after (post) 12 weeks 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 NCT02504866, which also lists 3 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 18 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.