Traumatic Brain InjuryNCT05130658
Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training
A study testing Virtual reality treadmill training and Treadmill Training in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study is to test the effectiveness of virtual reality (VR) based treadmill training on walking ability. The study will also help to understand the changes in cognitive ability and brain activity as a result of VR-based treadmill training after a brain injury. Read more about this study
- Who is it for?
- Ages 13 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Virtual reality treadmill training and Treadmill Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 29 Sep 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 13 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants must:
- Be TBI survivors > 6 months post TBI
- Be able to tolerate upright standing for up to 30 minutes.
- Have joint range of motion within normal functional limits for walking as determined by study staff.
- Be between 13-35 years of age.
- Be able to follow directions and commands.
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- Be able to communicate in English.
- Have stable blood pressure.
- Not been diagnosed with any cognitive (thinking) deficits.
- Participants must:
- Be able to tolerate upright standing for up to 30 minutes.
- Have joint range of motion within normal functional limits for ambulation.
- No history of orthopedic, neuromuscular, cognitive or neurological disorders.
- Be between 13-35 years of age.
- Have stable blood pressure; no diagnosis of persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in body weight support system).
- No diagnosed cognitive deficits.
Who cannot join
- Weight above 300lbs.
- Joint contracture or spasticity of any limb that limits normal range of motion during ambulation with assistive devices.
- Have any medical issue that prevents from supporting his/her weight (e.g. orthopedic injuries, pain, or severe spasticity).
- Have pre-existing condition that causes exercise intolerance (e.g. documented uncontrolled hypertension, coronary artery disease, irregular heart rate or rhythm, or congestive heart failure).
- Skin issues that would prevent from wearing a harness.
- Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
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- Have uncontrolled seizure disorder.
- Have uncontrolled spasticity that would interfere with walking.
- Diagnosed with cognitive (thinking) problems prior to TBI.
- Have neuromuscular or neurological issues (e.g. spinal cord injury, multiple sclerosis, or Parkinson's disease)
- Weight above 300lbs
- Joint contracture or spasticity of any limb that limits normal range of motion during ambulation with assistive devices.
- Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
- Pressure sore that would negatively affect weight bearing, or harness fit.
- Pre-existing condition that causes exercise intolerance.(Documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure)
- Hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
- Uncontrolled seizure disorder.
- Uncontrolled spasticity that would interfere with walking due to neuromuscular or neurological pathologies (e.g., Parkinson's disease, spinal cord injury, or multiple sclerosis) that will interfere with ambulation, or limit the range of motion of the lower limbs
- Diagnosed with cognitive deficits.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Kiran Karunakaran, PhD, 973-324-3590
Kiran Karunakaran, PhD
About this study
Official title: Pilot Study to Improve Ambulation in Individuals With Traumatic Brain Injury (TBI) Using Virtual Reality -Based Treadmill Training
The purpose of this research study is to test the effectiveness of virtual reality (VR) based treadmill training on walking ability. The study will also help to understand the changes in cognitive ability and brain activity as a result of VR-based treadmill training after a brain injury.
The study will include 3 groups: C-MILL training group (CTG), Treadmill training group (TTG), and healthy control group (HCG).
Read more
Individuals with brain injury will be randomly assigned to C-MILL training group, or Treadmill training group.
The CTG and TTG will participate in up to 13 sessions. The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions, one before the training and one after the training. The participants will undergo 10 training sessions. Individuals in the CTG will receive gait and balance training sessions with the virtual reality and auditory cues using C-MILL (such as walking on a pathway, obstacle avoidance, lateral balance etc.) to provide task specific training. C-Mill (Motekforce Link, Amsterdam, The Netherlands) is an instrumented treadmill that uses visual (on the screen as well on the treadmill) and acoustic cues for gait and balance training. The C-Mill allows for gait and balance adaptability strategy as it can provide obstacle avoidance environments, change in speed and various walking pathways in a safe and controlled environment.
Individuals in TTG group will walk on the treadmill (C-MILL) or stand on the treadmill (C-MILL) with no visual or auditory cues.
HCG will participate in up to four sessions. The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions and one C-MILLsession.
Each training session will last for 45 minutes. During the 45 minutes, the participants will perform the task for approximately 1 minute. Participants will be allowed as much rest as needed by them.
During the training all participants will wear the safety harness to protect from falling. In addition spotter will be present with the participants to prevent falls.
Data Collection:
Each participant's baseline and follow up data will be collected for a) functional b) neuromechanical c) cortical and d) cognitive outcomes. During walking on treadmill data will also be collected with instrumented C- MILL. C-MILL can provide gait parameters such as step length, width, frequency, speed and symmetry in addition to center of pressure for evaluation of gait and balance.
During Training Sessions: The instrumented treadmill will collect force data during training.
- Conditions
- Traumatic Brain Injury
- Being tested
- Virtual reality treadmill training, Treadmill Training
- 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.
Virtual reality treadmill trainingDevice
Also called C-MILL training, C-Mill (Motek, the Netherlands)
C-Mill (Motekforce Link, Amsterdam, The Netherlands) is an instrumented treadmill that uses visual (on the screen as well on the treadmill) and acoustic cues for gait and balance training. The C-Mill allows for gait and balance adaptability strategy as it can provide obstacle avoidance environments, change in speed and various walking pathways in a safe and controlled environment.
Treadmill TrainingOther
Conventional gait and balance training using treadmill.
| Study group | Role | What they receive |
|---|---|---|
| C-MILL training group | Experimental | The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions, one before the training and one after the training. The participants will undergo 10 training sessions. Individuals in the CTG will receive gait and balance training sessions with the virtual reality and auditory cues using C-MILL (such as walking on a pathway, obstacle avoidance, lateral balance etc.) to provide task specific training. C-Mill (Motekforce Link, Amsterdam, The Netherlands) is an instrumented treadmill that uses visual (on the screen as well on the treadmill) and acoustic cues for gait and balance training. The C-Mill allows for gait and balance adaptability strategy as it can provide obstacle avoidance environments, change in speed and various walking pathways in a safe and controlled environment. Receives: Device: Virtual reality treadmill training |
| Treadmill training group (TTG) | Active comparator | The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions, one before the training and one after the training. The participants will undergo 10 training sessions. Individuals in TTG group will walk on the treadmill (C-MILL) or stand on the treadmill (C-MILL) with no visual or auditory cues. Receives: Other: Treadmill Training |
| Healthy Control | No intervention | HCG will participate in up to four sessions. The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions and one C-MILL session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dynamic Gait Index (DGI)
DGI is a measurement tool commonly used to assess dynamic balance, gait and risk for falls. It consist of a total of eight gait assessments which can be scored on a four-point ordinal scale, ranging from 0-3, where '0' indicates the lowest level of function and '3' the highest level of function, allowing for a total possible score of 24.
Measured: 5 weeks
Change in Timed Up and Go (TUG)
TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair. The time taken to perform the task will be recorded using a stop watch. The TUG will be repeated multiple times. The participant may be asked to hold a plastic cup or count backwards by three from a randomly selected number while walking.
Measured: 5 weeks
Change in Six Minute Walk
Participants walk as far as possible for 6 minutes. They walk back and forth around the cones along an unobstructed pathway of 15 meters. They will be permitted to slow down or stop as necessary. The distance covered by the participant for the 6 minutes will be recorded at an interval of every 30 seconds using a measuring wheel and stop watch.
Measured: 5 weeks
Change in Ten Meter Walk Test
This is a walking test. I will be asked to walk as fast as I can at a safe speed for 10 meters (about 10 yards).
Measured: 5 weeks
Change in Temporal Characteristics using pressure mat
Participants will be asked to walk about 10 meters on a pressure mat. Pressure mat (ZenoMat, Protokinetics LLC) will be used to collect gait cycle times, in order to determine inter- and intra-limb temporal characteristics.
Measured: 5 weeks
Change in Spatial Characteristics
Participants will be asked to walk about 10 meters on a pressure mat. Pressure mat (ZenoMat, Protokinetics LLC) will be used to collect spatial parameters, in order to determine inter- and intra-limb spatial characteristics.
Measured: 5 weeks
Change in Silver Index
Silver index using Movendo Technology platform (Movendo Technology Srl,, Italy) is an objective test that enables to predict falls by assessing static and dynamic balance. Participants will be asked to stand on the Hunova platform. Silver index includes the following tasks: stand with eyes open or eyes closed, stand when the surface is perturbed, move torso on all four sides, perform sit to stand.
Measured: 5 weeks
Change in Cortical Activity
Cortical activity will be measured using 16 channel NIRSport 2 (NIRX Medical Technologies, LLC ), an Functional Near Infrared Spectroscopy (fNIRS) system. NIRSport 2 is a portable, non-invasive optical imaging technique to measure the cerebral hemodynamic response. fNIRS will be measure while the participants walks at a comfortable speed.
Measured: 5 weeks
Change in Trail Making Test A and B
The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper. Trail making Test A and B assess processing speed and executive function.
Measured: 5 weeks
Change in Montreal Cognitive Assessment Test
30-item question to assess cognitive impairment. MoCA is used to test orientation, attention, memory, and executive function.
Measured: 5 weeks
Secondary outcomes (4)
Change in Gait Kinematics
Natural Point's optitrack camera system will be used to collect joint angles at hip, knee and ankle using reflective markers placed on the anatomical joints.
Measured: 5 weeks
Change in Electromyography
Noraxon's surface Electromyography (EMG) wireless sensors will be used to measure the activation of tibialis anterior, soleus, vastus lateralis, rectus femoris, bicep femoris, and gastrocnemius during walking.
Measured: 5 weeks
Change in Continuous Performance Task (CPT)
The test requires a subject to click only when presented with a target. They must refrain from clicking if they see anything other than the target. To increase the difficulty, they will be asked to click if they see another stimuli before the target. CPT assesses sustained and selective attention.
Measured: 5 weeks
Change in C-MILL Force Data
Force data during walking and standing will be collected during training sessions by the C-MILL
Measured: 10 training sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start30 Sep 2020
- Primary completion29 Sep 2024 (estimated)
- Study completion29 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130658
- Sponsor's protocol ID
- R-1125-20
- Status last verified
- Dec 2023
- First submitted
- 16 Sep 2021
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Improve Ambulation in Individuals With Traumatic Brain Injury (TBI) Using Virtual Reality -Based Treadmill Training
- ClinicalTrials.gov ID
- NCT05130658
- Acronym / sponsor ID
- R-1125-20
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 29 Sep 2024 (estimated)
- Study completion
- 29 Sep 2024 (estimated)
- First posted
- 23 Nov 2021 (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 purpose of this research study is to test the effectiveness of virtual reality (VR) based treadmill training on walking ability. The study will also help to understand the changes in cognitive ability and brain activity as a result of VR-based treadmill training after a brain injury.
The study will include 3 groups: C-MILL training group (CTG), Treadmill training group (TTG), and healthy control group (HCG).
Individuals with brain injury will be randomly assigned to C-MILL training group, or Treadmill training group.
The CTG and TTG will participate in up to 13 sessions. The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions, one before the training and one after the training. The participants will undergo 10 training sessions. Individuals in the CTG will receive gait and balance training sessions with the virtual reality and auditory cues using C-MILL (such as walking on a pathway, obstacle avoidance, lateral balance etc.) to provide task specific training. C-Mill (Motekforce Link, Amsterdam, The Netherlands) is an instrumented treadmill that uses visual (on the screen as well on the treadmill) and acoustic cues for gait and balance training. The C-Mill allows for gait and balance adaptability strategy as it can provide obstacle avoidance environments, change in speed and various walking pathways in a safe and controlled environment.
Individuals in TTG group will walk on the treadmill (C-MILL) or stand on the treadmill (C-MILL) with no visual or auditory cues.
HCG will participate in up to four sessions. The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions and one C-MILLsession.
Each training session will last for 45 minutes. During the 45 minutes, the participants will perform the task for approximately 1 minute. Participants will be allowed as much rest as needed by them.
During the training all participants will wear the safety harness to protect from falling. In addition spotter will be present with the participants to prevent falls.
Data Collection:
Each participant's baseline and follow up data will be collected for a) functional b) neuromechanical c) cortical and d) cognitive outcomes. During walking on treadmill data will also be collected with instrumented C- MILL. C-MILL can provide gait parameters such as step length, width, frequency, speed and symmetry in addition to center of pressure for evaluation of gait and balance.
During Training Sessions: The instrumented treadmill will collect force data during training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C-MILL training group | Experimental | Device: Virtual reality treadmill trainingThe participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions, one before the training and one after the training. The participants will undergo 10 training sessions. Individuals in the CTG will receive gait and balance training sessions with the virtual reality and auditory cues using C-MILL (such as walking on a pathway, obstacle avoidance, lateral balance etc.) to provide task specific training. C-Mill (Motekforce Link, Amsterdam, The Netherlands) is an instrumented treadmill that uses visual (on the screen as well on the treadmill) and acoustic cues for gait and balance training. The C-Mill allows for gait and balance adaptability strategy as it can provide obstacle avoidance environments, change in speed and various walking pathways in a safe and controlled environment. |
| Treadmill training group (TTG) | Active comparator | Other: Treadmill TrainingThe participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions, one before the training and one after the training. The participants will undergo 10 training sessions. Individuals in TTG group will walk on the treadmill (C-MILL) or stand on the treadmill (C-MILL) with no visual or auditory cues. |
| Healthy Control | No intervention | –HCG will participate in up to four sessions. The participants will be screened for the inclusion/exclusion criteria and consented during the first session. They will participate in two data collection sessions and one C-MILL session. |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Be TBI survivors > 6 months post TBI
- Be able to tolerate upright standing for up to 30 minutes.
- Have joint range of motion within normal functional limits for walking as determined by study staff.
- Be between 13-35 years of age.
- Be able to follow directions and commands.
Key exclusion criteria (19 listed)
- Weight above 300lbs.
- Joint contracture or spasticity of any limb that limits normal range of motion during ambulation with assistive devices.
- Have any medical issue that prevents from supporting his/her weight (e.g. orthopedic injuries, pain, or severe spasticity).
- Have pre-existing condition that causes exercise intolerance (e.g. documented uncontrolled hypertension, coronary artery disease, irregular heart rate or rhythm, or congestive heart failure).
- Skin issues that would prevent from wearing a harness.
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 |
|---|---|---|
| Virtual reality treadmill trainingAlso: C-MILL training, C-Mill (Motek, the Netherlands)C-Mill (Motekforce Link, Amsterdam, The Netherlands) is an instrumented treadmill that uses visual (on the screen as well on the treadmill) and acoustic cues for gait and balance training. The C-Mill allows for gait and balance adaptability strategy as it can provide obstacle avoidance environments, change in speed and various walking pathways in a safe and controlled environment. | Device | C-MILL training group |
| Treadmill TrainingConventional gait and balance training using treadmill. | Other | Treadmill training group (TTG) |
Primary outcome
Change in Dynamic Gait Index (DGI)
Time frame: 5 weeks
DGI is a measurement tool commonly used to assess dynamic balance, gait and risk for falls. It consist of a total of eight gait assessments which can be scored on a four-point ordinal scale, ranging from 0-3, where '0' indicates the lowest level of function and '3' the highest level of function, allowing for a total possible score of 24.
Change in Timed Up and Go (TUG)
Time frame: 5 weeks
TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair. The time taken to perform the task will be recorded using a stop watch. The TUG will be repeated multiple times. The participant may be asked to hold a plastic cup or count backwards by three from a randomly selected number while walking.
Change in Six Minute Walk
Time frame: 5 weeks
Participants walk as far as possible for 6 minutes. They walk back and forth around the cones along an unobstructed pathway of 15 meters. They will be permitted to slow down or stop as necessary. The distance covered by the participant for the 6 minutes will be recorded at an interval of every 30 seconds using a measuring wheel and stop watch.
Change in Ten Meter Walk Test
Time frame: 5 weeks
This is a walking test. I will be asked to walk as fast as I can at a safe speed for 10 meters (about 10 yards).
Change in Temporal Characteristics using pressure mat
Time frame: 5 weeks
Participants will be asked to walk about 10 meters on a pressure mat. Pressure mat (ZenoMat, Protokinetics LLC) will be used to collect gait cycle times, in order to determine inter- and intra-limb temporal characteristics.
Change in Spatial Characteristics
Time frame: 5 weeks
Participants will be asked to walk about 10 meters on a pressure mat. Pressure mat (ZenoMat, Protokinetics LLC) will be used to collect spatial parameters, in order to determine inter- and intra-limb spatial characteristics.
Change in Silver Index
Time frame: 5 weeks
Silver index using Movendo Technology platform (Movendo Technology Srl,, Italy) is an objective test that enables to predict falls by assessing static and dynamic balance. Participants will be asked to stand on the Hunova platform. Silver index includes the following tasks: stand with eyes open or eyes closed, stand when the surface is perturbed, move torso on all four sides, perform sit to stand.
Change in Cortical Activity
Time frame: 5 weeks
Cortical activity will be measured using 16 channel NIRSport 2 (NIRX Medical Technologies, LLC ), an Functional Near Infrared Spectroscopy (fNIRS) system. NIRSport 2 is a portable, non-invasive optical imaging technique to measure the cerebral hemodynamic response. fNIRS will be measure while the participants walks at a comfortable speed.
Change in Trail Making Test A and B
Time frame: 5 weeks
The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper. Trail making Test A and B assess processing speed and executive function.
Change in Montreal Cognitive Assessment Test
Time frame: 5 weeks
30-item question to assess cognitive impairment. MoCA is used to test orientation, attention, memory, and executive function.
4 secondary outcomes
Change in Gait Kinematics
Time frame: 5 weeks
Change in Electromyography
Time frame: 5 weeks
Change in Continuous Performance Task (CPT)
Time frame: 5 weeks
Change in C-MILL Force Data
Time frame: 10 training sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality treadmill training and Treadmill Training in people with Traumatic Brain Injury, run by Kessler Foundation 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 16 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 19 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiran Karunakaran, Phd (973-324-3590, kkarunakaran@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dynamic Gait Index (DGI) (time frame: 5 weeks). The study lists 10 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 19 Dec 2023.