StrokeNOVUSNCT06761404
Non-invasive VNS in Stroke Recovery
A study testing taVNS in people with Stroke, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4).
- Age more than 18, Male or Female, All racial and ethnic groups
- Entry into the study >6 months post onset
- Patients who can safely undergo taVNS
- Able to follow 2 step commands
- Modified Ashworth Scale Score =<3 in the involved upper extremity
- Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand
- UFM =< 60 (scale 0-66)
Who cannot join
- Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions).
- Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
- Subjects with contraindication to MRI of the brain
- Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others).
- Patients with unstable cardiac arrhythmia, reentry tachycardia.
- Pregnancy
- Patients with pacemakers or stimulators that interfere with the stimulation, or other investigational devices or drugs
- Non-English speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However we plan to include them once funding has been secured in the subsequent larger trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Darrel Cleere, 713-441-3770, dwcleere@houstonmethodist.org
About this study
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
Read the detailed description
In this study, (Aim 1) we will test whether our non-invasive trans-auricular vagus nerve stimulation (taVNS) during occupational therapy task performance has the potential for large scale application through superior clinical benefit compared to sham in a broad group of stroke survivors including hemorrhagic strokes.
To determine the predictors of effective brain rewiring in the individual stroke patient, we will use an EEG and/or functional MRI (fMRI) connectivity biomarker independently of the success of the stimulation paradigm (Aim 2). We will test the hypothesis that better motor function will be associated with increased motor network connectivity pattern.
The central objective of this application is to determine whether taVNS significantly improves motor recovery for both ischemic and hemorrhagic strokes through increased connectivity as measured by a biomarker of plasticity. We address our objective through the following aims:
Aim 1: To determine the extent to which taVNS with concurrent occupational therapy (OT), causes significant, lasting motor gains in chronic stroke population
Hypothesis A: More chronic stroke patients treated with taVNS+OT will show clinically meaningful improved hand motor function over Sham+OT immediately after treatment as measured by upper extremity Fugl-Meyer (uFM) test response rate. 60 patients at least 6 months after ischemic or hemorrhagic stroke with persistent arm weakness will be enrolled in a 6-week double masked, sham-controlled, balanced parallel group design phase 2 clinical trial.
Hypothesis B: The sham group will achieve the same degree of motor function improvement in the open label cross-over phase as the original active taVNS group sustained clinical improvement after OT+VNS.
Hypothesis C: The open label home extension taVNS+OT phase will produce additional motor function improvement and will be associated with improved patient and caregiver satisfaction.
Aim 2: To determine the induced connectivity pattern of the brain resulting in the improved motor performance
Hypothesis A: Chronic stroke patients with improved motor performance will demonstrate increased connectivity between motor cortical areas as measured by high-definition EEG and/or fMRI functional connectivity compared to the non-responders immediately after treatment.
Hypothesis B: Network activation with taVNS is dependent on timing compared to movement and stimulation intensity. We will perform fMRI and /or high-definition EEG to evaluate network activity during taVNS at different intensity and phase of the movement.
This study evaluates the feasibility, efficacy and underlying plasticity changes of adjuvant noninvasive VNS to enhance motor recovery following ischemic and hemorrhagic strokes.
- Conditions
- Stroke
- Being tested
- taVNS
- Keywords
- taVNS, trans-auricular, non-invasive vagus nerve stimulation, stroke recovery, neuromodulation, rehabilitation, chronic stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Experimental. The current will be increased gradually for both sham and real stimulation at the beginning of the 90-minute stimulation to lessen the itchy/numb skin sensation and to create the same skin sensation for subject blinding.
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation | Sham comparator | Same procedure as with the active stimulation using the device's sham settings to elicit the same cutaneous sensation as the other stimulation conditions.. Receives: Device: taVNS |
| taVNS | Experimental | Weak current (up to 0.8-4 mA) will be delivered using pulses according to standard protocol during each motor task for up to 90-minutes through surface electrodes which will be administered using the intensity identified as resulting in well tolerated skin sensation and best motor performance during our initial testing session. Receives: Device: taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
To determine the extent to which taVNS with concurrent occupational therapy (OT), causes significant, lasting motor gains in chronic stroke population
Upper extremity Fugl-Meyer (uFM) The uFM test measures both proximal and distal upper extremity movements, ranges 0-66, higher score is better.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Secondary outcomes (16)
To evaluate the biomarkers of plasticity associated with VNS
We will use an EEG and/or functional MRI (fMRI) connectivity biomarker.
Measured: [Time Frame: Baseline 1(week 1), post-intervention (week 6), post intervention for sham crossover only (week 12)]
Wolf Motor Function Test (WMFT)
The WMFT is a time-based method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements. This measurement includes video recording of the task performance where de-identifying will be attempted to the degree possible (face not in the frame, removing/blocking out identifying jewelry etc.). All patients will sign an informed consent explicitly authorizing such video-recording.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Functional upper extremity levels (FUEL)
The FUEL is an upper extremity post-stroke motor function classification system that does not require significant extra time or evaluator training.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
NIH STROKE SCALE (NIHSS)
The NIHSS is a standardized clinical examination to evaluate clinical functional impairment after stroke.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Max score 42, minimum score 0. Score of 0 is best outcome
MRC grading scale
The MRC grading scale is a clinical scale to evaluate the motor impairment.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, max score 5 per item. 5 is normal, 0 is no movement.
Timed up and Go
This test assesses gait speed, mobility, balance, walking ability and fall risk in older adults.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Barthel Index (BI)
The Barthel Index is an index measuring the patients' activities of daily living and of patient's independence in mobility and personal care.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, maximum score 100. Higher score is better
Stroke Impact Scale (SIS)
A self-report questionnaire that evaluates disability and health-related quality of life after stroke from the perspective of the patient.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, maximum score 100. 0 means no recovery, 100 means fully recovered
Zarit Burden Interview: Short (12-items)
Caregiver perspective questionnaire to assess caregiver burden. Additional caregiver questionnaire for perception of user friendliness, time savings, helpfulness, ease of use, perceived improvement and free comments will be collected.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Modified Rankin Scale (mRS)
Clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke and as a primary end point in randomized clinical trials (RCTs) of emerging acute stroke treatments.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Modified Ashworth Spasticity Scale
The modified Ashworth spasticity scale provides a rating of the degree of spasticity of a limb evaluated by clinical neurologic examination.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR)
A validated 16-item0-27 scale self-report questionnaire of depression.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, maximum score greater than 21. 0-5 means normal, greater than 21 is not
taVNS questionnaire
Visual Analog Scale to prospectively evaluate taVNS effects such as skin sensation, tingling, skin redness etc. This will serve as a safety and tolerability measure.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Motor Activity log
A structured interview to assess how stroke survivors use their affected arm outside of the laboratory.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Wrist flexion-extension measurement
This measurement will be performed with our hand device to record maximum force of flexion and extension in standard arm position. taVNS test improvement will be calculated based on the speed and accuracy of the writs flexion measurement as described in our prior published work.
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
To determine the taVNS induced connectivity pattern of the brain
Primary outcome measure: Hypothesis A and Hypothesis B: Connectivity measure between motor cortical areas as measured by high definition EEG and fMRI functional connectivity in taVNS compared to Sham+OT immediately after treatment
Measured: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start15 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- Model description
- Sham stimulation vs taVNS
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timea Hodics, The Methodist Hospital Research Institute
- Investigators
- Timea Hodics, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761404
- Sponsor's protocol ID
- PRO00038365
- Acronym
- NOVUS
- Status last verified
- Feb 2026
- First submitted
- 13 Dec 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive VNS in Stroke Recovery
- ClinicalTrials.gov ID
- NCT06761404
- Acronym / sponsor ID
- NOVUS / PRO00038365
- Conditions
- Stroke
- Keywords
- taVNS, trans-auricular, non-invasive vagus nerve stimulation, stroke recovery, neuromodulation, rehabilitation, chronic stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 7 Jan 2025 (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.
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
Detailed description
In this study, (Aim 1) we will test whether our non-invasive trans-auricular vagus nerve stimulation (taVNS) during occupational therapy task performance has the potential for large scale application through superior clinical benefit compared to sham in a broad group of stroke survivors including hemorrhagic strokes.
To determine the predictors of effective brain rewiring in the individual stroke patient, we will use an EEG and/or functional MRI (fMRI) connectivity biomarker independently of the success of the stimulation paradigm (Aim 2). We will test the hypothesis that better motor function will be associated with increased motor network connectivity pattern.
The central objective of this application is to determine whether taVNS significantly improves motor recovery for both ischemic and hemorrhagic strokes through increased connectivity as measured by a biomarker of plasticity. We address our objective through the following aims:
Aim 1: To determine the extent to which taVNS with concurrent occupational therapy (OT), causes significant, lasting motor gains in chronic stroke population
Hypothesis A: More chronic stroke patients treated with taVNS+OT will show clinically meaningful improved hand motor function over Sham+OT immediately after treatment as measured by upper extremity Fugl-Meyer (uFM) test response rate. 60 patients at least 6 months after ischemic or hemorrhagic stroke with persistent arm weakness will be enrolled in a 6-week double masked, sham-controlled, balanced parallel group design phase 2 clinical trial.
Hypothesis B: The sham group will achieve the same degree of motor function improvement in the open label cross-over phase as the original active taVNS group sustained clinical improvement after OT+VNS.
Hypothesis C: The open label home extension taVNS+OT phase will produce additional motor function improvement and will be associated with improved patient and caregiver satisfaction.
Aim 2: To determine the induced connectivity pattern of the brain resulting in the improved motor performance
Hypothesis A: Chronic stroke patients with improved motor performance will demonstrate increased connectivity between motor cortical areas as measured by high-definition EEG and/or fMRI functional connectivity compared to the non-responders immediately after treatment.
Hypothesis B: Network activation with taVNS is dependent on timing compared to movement and stimulation intensity. We will perform fMRI and /or high-definition EEG to evaluate network activity during taVNS at different intensity and phase of the movement.
This study evaluates the feasibility, efficacy and underlying plasticity changes of adjuvant noninvasive VNS to enhance motor recovery following ischemic and hemorrhagic strokes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sham stimulation vs taVNS
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation | Sham comparator | Device: taVNSSame procedure as with the active stimulation using the device's sham settings to elicit the same cutaneous sensation as the other stimulation conditions.. |
| taVNS | Experimental | Device: taVNSWeak current (up to 0.8-4 mA) will be delivered using pulses according to standard protocol during each motor task for up to 90-minutes through surface electrodes which will be administered using the intensity identified as resulting in well tolerated skin sensation and best motor performance during our initial testing session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4).
- Age more than 18, Male or Female, All racial and ethnic groups
- Entry into the study >6 months post onset
- Patients who can safely undergo taVNS
- Able to follow 2 step commands
Key exclusion criteria (8 listed)
- Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions).
- Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
- Subjects with contraindication to MRI of the brain
- Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others).
- Patients with unstable cardiac arrhythmia, reentry tachycardia.
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 |
|---|---|---|
| taVNSExperimental. The current will be increased gradually for both sham and real stimulation at the beginning of the 90-minute stimulation to lessen the itchy/numb skin sensation and to create the same skin sensation for subject blinding. | Device | Sham Stimulation, taVNS |
Primary outcome
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
To determine the extent to which taVNS with concurrent occupational therapy (OT), causes significant, lasting motor gains in chronic stroke population Upper extremity Fugl-Meyer (uFM) The uFM test measures both proximal and distal upper extremity movements, ranges 0-66, higher score is better.
16 secondary outcomes
To evaluate the biomarkers of plasticity associated with VNS
Time frame: [Time Frame: Baseline 1(week 1), post-intervention (week 6), post intervention for sham crossover only (week 12)]
Wolf Motor Function Test (WMFT)
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Functional upper extremity levels (FUEL)
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
NIH STROKE SCALE (NIHSS)
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Max score 42, minimum score 0. Score of 0 is best outcome
MRC grading scale
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, max score 5 per item. 5 is normal, 0 is no movement.
Timed up and Go
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Barthel Index (BI)
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, maximum score 100. Higher score is better
Stroke Impact Scale (SIS)
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, maximum score 100. 0 means no recovery, 100 means fully recovered
Zarit Burden Interview: Short (12-items)
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Modified Rankin Scale (mRS)
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Modified Ashworth Spasticity Scale
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR)
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, maximum score greater than 21. 0-5 means normal, greater than 21 is not
taVNS questionnaire
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Motor Activity log
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Wrist flexion-extension measurement
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
To determine the taVNS induced connectivity pattern of the brain
Time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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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.
Timea Hodics, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with Stroke, run by The Methodist Hospital Research Institute 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darrel W Cleere, MPH (7134413770, dwcleere@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery (time frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]). 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 2 Mar 2026.