Non-invasive Vagus Nerve Stimulation for Acute Ischemic Stroke
This study is looking at whether a non-invasive treatment called transcutaneous auricular vagal nerve stimulation (taVNS) can help reduce inflammation and brain injury in people who have had a severe type of stroke called an acute ischemic stroke due to large vessel occlusion. Researchers want to see if adding taVNS to standard care can improve certain lab values related to brain injury and inflammation. You could be eligible if you are an adult (18-99 years old) who has had this type of stroke and can start treatment within 24 hours of symptoms. The study aims to measure changes in specific brain injury markers like Brain Derived Tau and Neurofilament light chain, and an inflammation marker called Interleukin-1b, all measured at 7 days after treatment. The study is currently recruiting about 65 participants, but its status is unclear.
- Study design
- This is a randomized, open-label pilot study with blinded outcome assessment, meaning participants will be randomly assigned to receive either the active device or a sham device, and about 65 people will participate.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurements for brain injury and inflammation markers are taken at 7 days after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemic Stroke
At a glance
Conditions
NCT07404852
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Barnes-Jewish Hospital
St Louis, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Brain Derived Tau7 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 chain7 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 Levels7 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 Levels7 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 Levels7 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.