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.
Adult patients who present with acute ischemic strokes due to large vessel occlusions
<18 years old
patients with presumed chronic large vessel occlusions
NIHSS<6
pre-morbid modified Rankin score (mRS) >2
Parallel
transcutaneous auricular vagal nerve stimulation
DeviceStimulus of the auricular branch of the vagal nerve with the transcutaneous auricular vagal nerve stimulation.
Sham transcutaneous vagal nerve stimulation
DevicePatients assigned to the controls arm will have no electricity applied to the Auricular Branch of the Vagus Nerve.
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.
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.
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.
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.
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.
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 1. = No significant disability despite symptoms; able to carry out all usual duties and activities 2. = Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3. = Moderate disability; requiring some help, but able to walk without assistance. 4. = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. = Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6. = Dead
Click on the lead sponsor to view all of their trials.
