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Mild Traumatic Brain InjuryNCT03479541

Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?

A study testing Timing of Rehabilitation and Biofeedback in people with Mild Traumatic Brain Injury and Balance; Distorted, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Every year 1.7 million people sustain a traumatic brain injury (TBI) in the United States and of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military populations and can be debilitating if symptoms do not resolve after injury. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Timing of Rehabilitation and Biofeedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteUnited States
Study dates
15 Jul 2018to 30 Sep 2023
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Inclusion criteria will consist of being 1) 18-60 years of age; 2) having no more than minimal cognitive impairment as assessed by the Short Blessed test; 3) having a physician-diagnosed mTBI and being within 2-12 weeks of the injury; and 4) endorsing ≥1 on either balance, dizziness, nausea, headache, or vision problems on the symptom evaluation scale from the Sport Concussion Assessment Tool (SCAT 5) and a total symptom severity score ≥15.

Who cannot join

  • Exclusion criteria will consist of: 1) having other musculoskeletal, neurological, or sensory deficits that could explain their dysfunction other than mTBI; 2) having moderate to severe substance use disorder within the past month; 3) experiencing severe pain during the evaluation (≥7/10 subjective rating), 4) are pregnant; and 5) are currently being treated by vestibular physical therapy; All participants will be asked to refrain from taking drugs that may influence balance including sedating antihistamines, benzodiazepines, sedatives, narcotic pain medications, and alcohol for at least 24 hours prior to testing.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

Other trials in United States

About this study

Official title: Sensory Integration Balance Deficits in Complex mTBI: Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes?

Every year 1.7 million people sustain a traumatic brain injury (TBI) in the United States and of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military populations and can be debilitating if symptoms do not resolve after injury. Balance problems are one of the most common complaints after sustaining a mTBI and often prevent individuals from returning to their previous quality of life. However, the investigators currently lack clear guidelines on when to initiate physical therapy rehabilitation and it is unclear if early physical therapy is beneficial. The investigators believe that the underlying problem of imbalance results from damage to parts of the brain responsible for interpreting sensory information for balance control. The investigators hypothesize that retraining the brain early, as opposed to months after injury, to correctly interpret sensory information will improve recovery. The investigators also believe this retraining is limited when rehabilitation exercises are performed incorrectly, and that performance feedback from wearable sensors, can improve balance rehabilitation. There are three objectives of this study: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of balance exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system using wearable sensors to provide the physical therapist information, in real-time during training, about quality of head and trunk movements during prescribed exercises. The findings from this research could be very readily adopted into military protocols for post-mTBI care and have the potential to produce better balance rehabilitation and quality of life for mTBI patients and their families.

Read the detailed description

Although balance is one of the most common and debilitating complaints after mTBI, the investigators currently lack clear guidelines on when to initiate balance rehabilitation and it is unclear if early physical therapy is beneficial. There is a clear gap in clinical care guidelines after mTBI and it is unclear if initiating rehabilitation early would improve outcomes related to imbalance. Measures of imbalance are subjective and are easily overlooked as a treatable deficit. Even with rehabilitation, recovery of balance in people with mTBI is challenging, particularly in people with central vestibular and sensory integration deficits.

Although vestibular and balance rehabilitation after mTBI relies heavily on a home exercise program and repetition is essential for recovery; The slow progress in balance rehabilitation may be partially due to an inability of people with mTBI to correctly perform the prescribed rehabilitation exercises on their own. Biofeedback is a clinical technique that provides physiologic information that would otherwise be unknown to patients and may improve outcomes after mTBI. There are no commercially available systems to provide the physical therapist and/or patient objective information on the quality of head movements during training of rehabilitation tasks that involve balance and walking.

Therefore, the three objectives of this study are: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of home balance exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system using wearable sensors to provide the physical therapist information, in real-time during training, about quality of head and trunk movements during prescribed exercises.

160 individuals with subacute mTBI within 2-12 weeks of the injury will be randomly assigned to receive earlier onset of physical therapy (n=80) right away or be randomly assigned to receive later rehabilitation 6 weeks after enrollment in the standard of care physical therapy group (n=80). A subgroup of participants in the earlier physical therapy (n=40) and standard of care physical therapy (n=40) will be randomly assigned to home monitoring. The participants in the home monitoring subgroups will wear wireless sensors while completing the rehabilitation program to better inform the physical therapist of their progress.

The outcome measures will consist of a battery of self-reported questionnaires, and balance and gait measures and will be tested at Pre I (baseline), Pre 2 (6 weeks after baseline for the later physical therapy group), Post (after the intervention), and Retention (6 month follow-up). Peripheral vestibular and ocular motor assessments will occur at the baseline visit only.

The central hypothesis is that rehabilitation after mTBI is suboptimal due to late initiation of and inadequate performance of exercises that do not adequately challenge vestibular and sensory integration function. The long-term goal is to clarify best practices for the rehabilitation of balance deficits in people with mTBI by comparing earlier vs later (standard of care) initiation of physical therapy with and without wearable sensors on balance deficits after mTBI. The findings from this research could be very readily adopted into military protocols for post-mTBI care and have the potential to produce better balance rehabilitation and quality of life for mTBI patients and their families.

Being tested
Timing of Rehabilitation, Biofeedback
Keywords
mild traumatic brain injury, vestibular impairment, balance and gait, dual-tasking, veterans, quality of life, rehabilitation
Medical subject headings
Brain Concussion, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Timing of RehabilitationBehavioural

    Participants in the Earlier Physical Therapy group will start physical therapy within a week of enrollment and baseline testing. Participants allocated to the Later Physical Therapy group will wait 6 weeks after enrollment and baseline testing before starting physical therapy, and re-test on study outcomes before starting physical therapy. Both groups will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each session will last 60 minutes and consist of cardiovascular, cervical spine, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for 30 minutes with similar subcategories from the in-person sessions. Both the in-person physical therapy and home exercises will be individualized and progressive at the discretion of the physical therapist depending on the performance of the participant.

  • BiofeedbackBehavioural

    Wearable sensors measure movement during the home exercise program for later feedback.

Study groups in NCT03479541
Study groupRoleWhat they receive
Earlier Physical TherapyExperimentalWithin a week of enrollment and baseline testing, participants (n=80) will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks.
Receives: Behavioral: Timing of Rehabilitation
Later Physical Therapy (Standard of Care)Active comparatorParticipants (n=80) will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes.
Receives: Behavioral: Timing of Rehabilitation
Physical Therapy with Home MonitoringExperimentalParticipants (n=80) will start physical therapy after baseline testing and use wearable sensors during home exercise. Feedback was provided later at the next physical therapy session.
Receives: Behavioral: Biofeedback
Physical Therapy (without home monitoring)Active comparatorParticipants (n=80) will start physical therapy after baseline testing and did not use wearable sensors during home exercise. No feedback of performance was provided.
Receives: Behavioral: Biofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dizziness Handicap Inventory (DHI)

    Self-rated questionnaire for dizziness impairment rated on a 3-point scale (0: no; 2: sometimes; 4: always) with a maximum score of 100. Higher scores indicate worse outcome.

    Measured: Earlier Physical Therapy (PT) Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

Secondary outcomes (20)

  1. Neurobehavioral Symptom Inventory (NSI)

    Self-rated questionnaire (~5 minutes) for symptom severity on a scale from 0 (none) to 4 (very severe) with a maximum score of 88. High scores indicate worse outcomes.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  2. Quality of Life After Brain Injury (QOLIBRI)

    Self-rated questionnaire for quality of life questioning satisfaction on a scale from 0 (not at all) to 4 (very). Scores are transformed to a scale of 0 to 100. Lower scores indicate worse outcomes.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  3. Patient Global Impression of Change (PGIC)

    This single questionnaire will ask the participant to rate how they perceive their health has changed over the course of treatment. Scores range from 1 to 7 with lower scores indicating worse performance.

    Measured: Earlier PT Group: Post PT (week 7) / Later PT Group: Post PT (week 14)

  4. Return to Activity Question

    One question asking participants how recovered they feel on a 0 (not at all recovered) to 100% (fully recovered and returned to pre-injury level) scale. Lower scores indicate worse outcomes.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  5. Dynamic Visual Acuity (DVA)

    Physical assessment that assesses gaze stability during head rotations (horizontal and vertical) relative to head-stationary visual acuity. Higher scores indicate worse outcome.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Pre (week 7), and Post Physical Therapy (week 14)

  6. Vestibular/Ocular-Motor Screening (VOMS) Tool

    Physical assessment (~10 minutes) to assess the function of the vestibular- and ocular-motor system, and clinically reporting symptoms of headache, dizziness, nausea, and fogginess during each visual task on a 10-point scale (0: no symptoms; 10 severe symptoms). The total symptom provocation change scores range from 0 to 280. High scores indicate worse outcomes.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  7. Mini-Balance Evaluation Systems Test (Mini-BESTest)

    Physical assessment (~20 minutes) to quantify balance and clinically scored on a 3-point scale (0: severe; 2: normal) with a maximum score of 28. Lower scores indicate worse outcomes.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  8. Modified Balance Error Scoring System (mBESS)

    Physical assessment (~5 min) that is clinically scored on a scale from 0-10 (0: no errors; 10: 10 or more errors) for each of the three conditions. High scores indicate worse outcomes.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  9. Automated Neuropsychological Assessment Metrics (ANAM)

    20-minute Computer-based test of cognition. Composite scores range from -4 to +4. Lower scores indicate worse outcome.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  10. Instrumented Sway

    Participants stand with feet together with eyes closed on a firm (EcFi) and Foam (EcFo) surface for 30 seconds. An inertial sensor around the waist measures the sway area. Larger areas indicate worse performance.We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  11. Complex Navigation Task

    Physical assessment using wearable inertial sensors to quantify the average time to navigate a lap of a complex course (total 8 laps). Participants walk at a self-selected pace around the course under single-task and dual-task auditory Stroop conditions. Longer lap times indicate worse outcomes.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  12. Instrumented Walking: Gait Speed

    Physical assessment using wearable inertial sensors to quantify gait kinematics when walking at a self-selected pace in a straight line (9m) with and without the auditory Stroop. Gait speed at enrollment (m/s). Slower gait speeds and slower turning velocity indicate worse outcomes.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  13. Instrumented Walking: 180 Degree Turn Velocity

    Physical assessment using wearable inertial sensors to quantify gait kinematics when walking at a self-selected pace in a straight line (9m) with and without the auditory Stroop. Measure: 180-degree turning speed. Slower turning velocities indicate worse outcomes. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  14. Instrumented Walking: Percentage of Double Support of Gait Cycle

    Physical assessment using wearable inertial sensors to quantify gait kinematics when walking at a self-selected pace in a straight line (9m) with and without the auditory Stroop. Percentage of gait cycle in double support were the outcome measure. Larger percentages of double support time indicate worse outcomes.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  15. Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting

    Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate sensory weighting. This outcome is unitless for the weights as they are percentage values (0-1). We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  16. Central Sensorimotor Integration (CSMI) Test: Time Delay

    Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate time delay within the neural controller. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  17. Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness

    Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate normalized stiffness for neural controller. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  18. Central Sensorimotor Integration (CSMI) Test: Normalized Damping

    Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate normalized damping for neural controller. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  19. Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway

    Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate evoked center-of-mass (CoM) sway. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

  20. Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise

    Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to internal sensory noise. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.

    Measured: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2018
  2. Study start15 Jul 2018
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03479541
Sponsor's protocol ID
DOD2
Other IDs
W81XWH-17-1-0424
Status last verified
Jun 2025
First submitted
15 Feb 2018
Last updated
24 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Faul, M., Xu, L., Wald, M. M., & Coronado, V.G. (2010). Traumatic brain injury in the United States: Emergency Department Visits, Hospitalizations and Deaths 2002-2006. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. https://www.cdc.gov/traumaticbraininjury/pdf/blue_book.pdf

  • Pfaltz CR, Kamath R. Central compensation of vestibular dysfunction. I. Peripheral lesions. Pract Otorhinolaryngol (Basel). 1970;32(6):335-49. doi: 10.1159/000274957. No abstract available.

    PubMed 5313795

  • Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9.

    PubMed 7816453

  • Campbell KR, Antonellis P, Peterka RJ, Wilhelm JL, Scanlan KT, Pettigrew NC, Chen S, Parrington L, Fino PC, Chesnutt JC, Horak FB, Hullar TE, King LA. In People With Subacute Mild Traumatic Brain Injury, Earlier Physical Therapy Improved Symptoms at a Faster Rate Than Later Physical Therapy: Randomized Controlled Trial. Phys Ther. 2025 Feb 6;105(2):pzae180. doi: 10.1093/ptj/pzae180.

    PubMed 39693261

  • Campbell KR, Scanlan KT, Wilhelm JL, Brumbach BH, Pettigrew NC, Neilson A, Parrington L, King LA. Assessment of balance in people with mild traumatic brain injury using a balance systems model approach. Gait Posture. 2023 Feb;100:107-113. doi: 10.1016/j.gaitpost.2022.12.005. Epub 2022 Dec 7.

    PubMed 36516644

  • Campbell KR, Wilhelm JL, Pettigrew NC, Scanlan KT, Chesnutt JC, King LA. Implementation and Adoption of Telerehabilitation for Treating Mild Traumatic Brain Injury. J Neurol Phys Ther. 2022 Oct 1;46(4):E1-E10. doi: 10.1097/NPT.0000000000000409. Epub 2022 Jun 6.

    PubMed 35666882

  • Parrington L, Jehu DA, Fino PC, Stuart S, Wilhelm J, Pettigrew N, Murchison CF, El-Gohary M, VanDerwalker J, Pearson S, Hullar T, Chesnutt JC, Peterka RJ, Horak FB, King LA. The Sensor Technology and Rehabilitative Timing (START) Protocol: A Randomized Controlled Trial for the Rehabilitation of Mild Traumatic Brain Injury. Phys Ther. 2020 Apr 17;100(4):687-697. doi: 10.1093/ptj/pzaa007.

    PubMed 31951263

Questions about this trial

What is this clinical trial studying?

A study testing Timing of Rehabilitation and Biofeedback in people with Mild Traumatic Brain Injury and Balance; Distorted, run by Oregon Health and Science University 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 Jun 2025. 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 24 Jun 2025). 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?

Dizziness Handicap Inventory (DHI) (time frame: Earlier Physical Therapy (PT) Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)). 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 NCT03479541, which also lists 7 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 Jun 2025.

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