Large Vessel OcclusionNUVISTA2NCT07404852
Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemic Stroke
A study testing transcutaneous auricular vagal nerve stimulation in people with Large Vessel Occlusion and Acute Ischemic Stroke, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory and brain injury laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Large Vessel Occlusion, Acute Ischemic Stroke
- What is being tested?
- transcutaneous auricular vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to 29 Feb 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who present with acute ischemic strokes due to large vessel occlusions
Who cannot join
- <18 years old
- patients with presumed chronic large vessel occlusions
- NIHSS<6
- pre-morbid modified Rankin score (mRS) >2
- unable to initiate treatment under 24 hours from symptom discovery
- Chronic or acute infection, Recent surgery, active immune disease
Show all 9Show fewer
- life expectancy <3 months
- patients' undergoing active cancer or immunosuppressive/modulating therapy
- patients with sustained bradycardia on arrival with a heart rate <50 beats per minute.
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
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Angela Birke, MS, (314) 362-5291, birkea@wustl.edu
Osvaldo J Laurido-Soto, MD, ojlaurido-soto@wustl.edu
About this study
Official title: Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct 2
This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory and brain injury laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted management in addition to transcutaneous auricular vagal nerve stimulation.
Read the detailed description
Ischemic stroke is a leading cause of death and long-term disability worldwide. Large vessel occlusion (LVO) accounts for ~38% of acute ischemic strokes (AIS) and is associated with disproportionately poor outcomes: without treatment, 64% of patients are dead or dependent at six months, and even after successful mechanical thrombectomy, nearly half have poor functional recovery. These data highlight a critical unmet need for adjunctive therapies that limit secondary brain injury following reperfusion.
Neuroinflammation is a major contributor to ischemic brain injury and neurologic deterioration after AIS. In experimental models, inhibition of inflammatory pathways reduces infarct size and improves outcomes, and in human AIS, elevations in pro-inflammatory cytokines are associated with worse recovery. However, clinical trials targeting individual inflammatory mediators have failed, suggesting that effective therapy may require coordinated modulation of multiple immune pathways rather than blockade of a single target. Vagus nerve stimulation (VNS) engages an evolutionary conserved neuroimmune reflex that broadly regulates innate and adaptive immune responses. While implantable VNS is not feasible in acute stroke, non-invasive transauricular VNS (taVNS) enables rapid deployment in emergent settings.
The investigators recently completed the Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct (NUVISTA) pilot randomized trial (n=35) in AIS patients with LVO. taVNS was rapidly deployable and safe, significantly attenuated the trajectory of plasma interleukin-6 (IL-6) and other inflammatory mediators, and demonstrated encouraging signals of improved clinical outcomes. These findings support further mechanistic and translational investigation in a well-powered cohort.
The central hypothesis of this proposal is that taVNS engages endogenous neuroimmune reflexes to reprogram peripheral immune responses following LVO AIS, resulting in reduced systemic inflammation, attenuation of neuroaxonal injury, and improved early recovery. The investigators will test this hypothesis in a randomized, sham-controlled clinical study of 65 AIS patients
Patients enrolled in the trial will be randomized to treatment with electrical stimulation to the auricular branch of the vagus nerve (intervention) or no stimulation to the auricular branch (Sham) via an auricular, transcutaneous vagus nerve stimulator. All patients will be fitted with the device, the investigators will attach the ear electrodes to the left ear. Stimulation sessions will occur for 20 minutes twice daily during the inpatient period. Patients will have electricity applied to the different nerves depending on the randomization, they will be treated with stimulation with the following parameters: frequency 20 Hz, pulse width 250 μm, and a fixed intensity of 0.5 milliampere. The amplitude of stimulation may be reduced if a patient complains of discomfort at the site of stimulation. The site of stimulation will be inspected daily before and after treatment to ensure there is no redness or irritation at the site. The investigators will obtain laboratory samples on admission, day 0, and every 1.5 days till day 7 or discharge (whichever occurs first) to assess the patients inflammatory markers.
- Conditions
- Large Vessel Occlusion, Acute Ischemic Stroke
- Being tested
- transcutaneous auricular vagal nerve stimulation, Sham transcutaneous vagal nerve stimulation
- Keywords
- Acute ischemic stroke, large vessel occlusion, cytokines, vagus nerve stimulator, brain injury biomarkers
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagal nerve stimulationDevice
Stimulus of the auricular branch of the vagal nerve with the transcutaneous auricular vagal nerve stimulation.
Sham transcutaneous vagal nerve stimulationDevice
Patients assigned to the controls arm will have no electricity applied to the Auricular Branch of the Vagus Nerve.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator | Experimental | All patients will be fitted with the device, the investigator will attach an electrode to the left ear. Stimulation sessions will occur for 20 minutes twice daily during the inpatient period, the investigator will stimulate the auricular branch of the vagus nerve. Patients' will be treated with the following parameters: frequency 20 Hz, pulse width 250 μm, and and a fixed intensity of 0.5 milliampere. Receives: Device: transcutaneous auricular vagal nerve stimulation |
| Control - No Stimulation Transcutaneous Auricular Vagal Nerve Stimulator | Sham comparator | All patients will be fitted with the device, the investigator will attach an electrode to the left ear. Sham stimulation sessions will occur for 20 minutes twice daily during the inpatient period. Patients assigned to the controls arm will have no electricity applied to the auricular branch of the vagus nerve. Receives: Device: Sham transcutaneous vagal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Derived Tau
The primary endpoints of the study will include changes in the levels of brain injury biomarkers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Brain Derived Tau (BD-tau). The investigators will measure BD-tau in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 48 to 68 kilodalton specific to BD-tau. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
Measured: 7 days
Neurofilament light chain
The primary endpoints of the study will include changes in the levels of brain injury biomarkers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Neurofilament light chain (NfL). The investigators will measure NfL in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 68-70 kilodalton specific to NfL. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
Measured: 7 days
Interleukin - 1b - Changes and Differences in the Levels
The primary endpoints of the study will include changes in the levels of inflammatory markers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Interleukin (IL) -1b. The investigators will measure IL-1b in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 17-31 kilodalton specific to IL-1b. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
Measured: 7 days
Interleukin - 6 - Changes and Differences in the Levels
The primary endpoints of the study will include changes in the levels of inflammatory markers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Interleukin (IL) - 6. The investigators will measure IL-6 in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 26 kilodalton specific to IL-6. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
Measured: 7 days
Tumor Necrosis Factor Alpha - Changes and Differences in the Levels
The primary endpoints of the study will include changes in the levels of inflammatory markers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Tumor necrosis factor alpha (TNF-a). The investigators will measure IL-1b in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 17 kilodalton specific to TNF-a. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
Measured: 7 days
Secondary outcomes (2)
Change in NIH Stroke Scale (NIHSS)
This is a clinical secondary exploratory endpoints. The NIH Stroke Scale (NIHSS) is a clinical tool used to assess stroke severity, the score ranges from 0 up to 42 (higher is more severe). It will be assessed daily by the investigators and at time of discharge. The investigators will assess differences in NIHSS dependent of the intervention arm.
Measured: 7 days
Modified Ranking Scale (mRS)
This is a clinical secondary exploratory endpoints. The Modified Ranking Scale (mRS) is a clinical tool used to assess functional status after suffering a stroke. It ranges from 0 up to 6. It will be assessed at day 90 over the phone. The investigators will assess differences in mRS dependent of the intervention arm.
0 = no symptoms at all
- = No significant disability despite symptoms; able to carry out all usual duties and activities
- = Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.
- = Moderate disability; requiring some help, but able to walk without assistance.
- = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- = Severe disability; bedridden, incontinent and requiring constant nursing care and attention.
- = Dead
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start23 Feb 2026
- Primary completion29 Nov 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Large Vessel OcclusionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory and brain injury laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted management in addition to transcutaneous auricular vagus nerve stimulation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo J. Laurido-Soto, MD, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404852
- Sponsor's protocol ID
- 202601166
- Acronym
- NUVISTA2
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified patient level data may be shared upon reasonable requested and approval by the institutions Human Research Protection Office
Publications
Laurido-Soto OJ, Tan G, Nielsen SS, Huguenard AL, Donovan KM, Xu I, Giles J, Dhar R, Adeoye O, Lee JM, Leuthardt E. Transcutaneous Auricular Vagus Nerve Stimulation Reduces Inflammatory Biomarkers after Large Vessel Occlusion Stroke: Results of a Prospective Randomized Open-Label Blinded Endpoint Trial. Transl Stroke Res. 2025 Dec 22;17(1):7. doi: 10.1007/s12975-025-01405-6.
PubMed 41428140
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct 2
- ClinicalTrials.gov ID
- NCT07404852
- Acronym / sponsor ID
- NUVISTA2 / 202601166
- Conditions
- Large Vessel Occlusion, Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, large vessel occlusion, cytokines, vagus nerve stimulator, brain injury biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 29 Nov 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 12 Feb 2026 (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.
This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory and brain injury laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted management in addition to transcutaneous auricular vagal nerve stimulation.
Detailed description
Ischemic stroke is a leading cause of death and long-term disability worldwide. Large vessel occlusion (LVO) accounts for ~38% of acute ischemic strokes (AIS) and is associated with disproportionately poor outcomes: without treatment, 64% of patients are dead or dependent at six months, and even after successful mechanical thrombectomy, nearly half have poor functional recovery. These data highlight a critical unmet need for adjunctive therapies that limit secondary brain injury following reperfusion.
Neuroinflammation is a major contributor to ischemic brain injury and neurologic deterioration after AIS. In experimental models, inhibition of inflammatory pathways reduces infarct size and improves outcomes, and in human AIS, elevations in pro-inflammatory cytokines are associated with worse recovery. However, clinical trials targeting individual inflammatory mediators have failed, suggesting that effective therapy may require coordinated modulation of multiple immune pathways rather than blockade of a single target. Vagus nerve stimulation (VNS) engages an evolutionary conserved neuroimmune reflex that broadly regulates innate and adaptive immune responses. While implantable VNS is not feasible in acute stroke, non-invasive transauricular VNS (taVNS) enables rapid deployment in emergent settings.
The investigators recently completed the Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct (NUVISTA) pilot randomized trial (n=35) in AIS patients with LVO. taVNS was rapidly deployable and safe, significantly attenuated the trajectory of plasma interleukin-6 (IL-6) and other inflammatory mediators, and demonstrated encouraging signals of improved clinical outcomes. These findings support further mechanistic and translational investigation in a well-powered cohort.
The central hypothesis of this proposal is that taVNS engages endogenous neuroimmune reflexes to reprogram peripheral immune responses following LVO AIS, resulting in reduced systemic inflammation, attenuation of neuroaxonal injury, and improved early recovery. The investigators will test this hypothesis in a randomized, sham-controlled clinical study of 65 AIS patients
Patients enrolled in the trial will be randomized to treatment with electrical stimulation to the auricular branch of the vagus nerve (intervention) or no stimulation to the auricular branch (Sham) via an auricular, transcutaneous vagus nerve stimulator. All patients will be fitted with the device, the investigators will attach the ear electrodes to the left ear. Stimulation sessions will occur for 20 minutes twice daily during the inpatient period. Patients will have electricity applied to the different nerves depending on the randomization, they will be treated with stimulation with the following parameters: frequency 20 Hz, pulse width 250 μm, and a fixed intensity of 0.5 milliampere. The amplitude of stimulation may be reduced if a patient complains of discomfort at the site of stimulation. The site of stimulation will be inspected daily before and after treatment to ensure there is no redness or irritation at the site. The investigators will obtain laboratory samples on admission, day 0, and every 1.5 days till day 7 or discharge (whichever occurs first) to assess the patients inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory and brain injury laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted management in addition to transcutaneous auricular vagus nerve stimulation.
| Arm | Type | Receives |
|---|---|---|
| Treatment - Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator | Experimental | Device: transcutaneous auricular vagal nerve stimulationAll patients will be fitted with the device, the investigator will attach an electrode to the left ear. Stimulation sessions will occur for 20 minutes twice daily during the inpatient period, the investigator will stimulate the auricular branch of the vagus nerve. Patients' will be treated with the following parameters: frequency 20 Hz, pulse width 250 μm, and and a fixed intensity of 0.5 milliampere. |
| Control - No Stimulation Transcutaneous Auricular Vagal Nerve Stimulator | Sham comparator | Device: Sham transcutaneous vagal nerve stimulationAll patients will be fitted with the device, the investigator will attach an electrode to the left ear. Sham stimulation sessions will occur for 20 minutes twice daily during the inpatient period. Patients assigned to the controls arm will have no electricity applied to the auricular branch of the vagus nerve. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who present with acute ischemic strokes due to large vessel occlusions
Key exclusion criteria (9 listed)
- <18 years old
- patients with presumed chronic large vessel occlusions
- NIHSS<6
- pre-morbid modified Rankin score (mRS) >2
- unable to initiate treatment under 24 hours from symptom discovery
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 |
|---|---|---|
| transcutaneous auricular vagal nerve stimulationStimulus of the auricular branch of the vagal nerve with the transcutaneous auricular vagal nerve stimulation. | Device | Treatment - Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator |
| Sham transcutaneous vagal nerve stimulationPatients assigned to the controls arm will have no electricity applied to the Auricular Branch of the Vagus Nerve. | Device | Control - No Stimulation Transcutaneous Auricular Vagal Nerve Stimulator |
Primary outcome
Brain Derived Tau
Time frame: 7 days
The primary endpoints of the study will include changes in the levels of brain injury biomarkers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Brain Derived Tau (BD-tau). The investigators will measure BD-tau in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 48 to 68 kilodalton specific to BD-tau. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
Neurofilament light chain
Time frame: 7 days
The primary endpoints of the study will include changes in the levels of brain injury biomarkers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Neurofilament light chain (NfL). The investigators will measure NfL in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 68-70 kilodalton specific to NfL. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
Interleukin - 1b - Changes and Differences in the Levels
Time frame: 7 days
The primary endpoints of the study will include changes in the levels of inflammatory markers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Interleukin (IL) -1b. The investigators will measure IL-1b in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 17-31 kilodalton specific to IL-1b. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
Interleukin - 6 - Changes and Differences in the Levels
Time frame: 7 days
The primary endpoints of the study will include changes in the levels of inflammatory markers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Interleukin (IL) - 6. The investigators will measure IL-6 in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 26 kilodalton specific to IL-6. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
Tumor Necrosis Factor Alpha - Changes and Differences in the Levels
Time frame: 7 days
The primary endpoints of the study will include changes in the levels of inflammatory markers measured at onset and every 1.5 days till day 7, or discharge (whichever occurs first), this includes: Tumor necrosis factor alpha (TNF-a). The investigators will measure IL-1b in aliquots from the plasma with mononuclear antibodies that recognizes a protein of 17 kilodalton specific to TNF-a. A functional assay will be measured in picogram/milliliter. Will utilize a high sensitivity assays to minimize floor effects.
2 secondary outcomes
Change in NIH Stroke Scale (NIHSS)
Time frame: 7 days
Modified Ranking Scale (mRS)
Time frame: 90 days
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 13 Apr 2026.
- Background: PubMed 41428140Laurido-Soto OJ, Tan G, Nielsen SS, Huguenard AL, Donovan KM, Xu I, Giles J, Dhar R, Adeoye O, Lee JM, Leuthardt E. Transcutaneous Auricular Vagus Nerve Stimulation Reduces Inflammatory Biomarkers after Large Vessel Occlusion Stroke: Results of a Prospective Randomized Open-Label Blinded Endpoint Trial. Transl Stroke Res. 2025 Dec 22;17(1):7. doi: 10.1007/s12975-025-01405-6.
- Individual participant dataSharing planned: Yes. De-identified patient level data may be shared upon reasonable requested and approval by the institutions Human Research Protection Office
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular vagal nerve stimulation in people with Large Vessel Occlusion and Acute Ischemic Stroke, run by Washington University School of Medicine 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 9 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 13 Apr 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 Angela Birke, MS ((314) 362-5291, birkea@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Derived Tau (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07404852, which also lists 1 linked publication.
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 13 Apr 2026.