Blood Biomarkers, Hemostasis
Conditions
Keywords
Transcutaneous auricular neurostimulation, Transcutaneous auricular vagus nerve stimulation, Blood biomarkers, Neurostimulation, Healthy human
Brief summary
This study is designed as a randomized, double-blind, sham-controlled, single-center research study in which healthy adults will be randomized 1:1 into one of two experimental groups, to receive transcutaneous auricular vagus nerve stimulation (taVNS) targeting either the auricular branch of the vagus nerve (ABVN) or tAN, which targets the ABVN and the auriculotemporal nerve (ATN): 1. Group 1: Sham taVNS followed by active taVNS 2. Group 2: Sham tAN followed by active tAN Participants will receive 30 minutes of sham stimulation (taVNS or tAN), followed by active stimulation (taVNS or tAN). Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device.
Interventions
DEVICEVolta System
The Volta System is a wearable, battery-operated, neurostimulation system designed to deliver tAN or taVNS. The device will be used to deliver two 30-minute sessions of active or sham therapy according to the participant's randomization group (taVNS or tAN).
Sponsors
Northwell Health
Spark Biomedical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants will be randomized into two 30-minute stimulation sessions. One session will be active and the other sham. Participants are blinded to treatment group as well as the stimulation session.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participant is between 18 and 65 years of age 2. Participant is English proficient 3. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
Exclusion criteria
1. Participant has a history of thrombocytopenia (platelet count \<100k) 2. Participant has reported coagulopathy (elevated prothrombin time (PT), elevated partial thromboplastin time (PTT), elevated activated clotting time (ACT)) 3. Participant has internal bleeding, external bleeding, easy bruising 4. Participant has a history of abnormal bleeding or blood disorder, including anemia or anemia-related disorders 5. Participant has a history of coagulopathy, including hemophilia, stroke, pulmonary embolism, myocardial infarction, or deep vein thromboses 6. Participant has a history of conditions that can cause coagulopathic conditions, including atrial fibrillation, heart valve surgery or replacement, hip or knee replacement, or clotting disorders 7. Participants using coagulation- or platelet-modifying therapies such as clotting factor products, emicizumab, desmopressin acetate, epsilon amino caproic acid, heparin and its derivatives, argatroban, desirudin, bivalirudin, warfarin, dabigatran, apixaban, edoxaban, betrixaban, or aspirin 8. Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months 9. Participant has consumed caffeine within the past 12 hours 10. Participant has received a blood transfusion within 30 days prior to study 11. Participant has a history of epileptic seizures 12. Participant has a history of neurologic diseases or traumatic brain injury 13. Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) 14. Participant has abnormal ear anatomy or ear infection present 15. Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study 16. Females who are pregnant, lactating or menstruating 17. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker of hemostasis (tissue anti-thrombin (TAT) complex) in blood shed from fingerstick | From collection up to 240 minutes, assessed upon receipt of assay results (up to one month) | Mean TAT levels in shed blood after active stimulation versus sham stimulation within each group |
| Biomarkers of hemostasis (TAT complex, D-dimer, viscoelasticity, coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) in circulating blood | From collection up to 240 minutes, assessed upon receipt of assay results (up to one month) | Mean coagulation biomarker levels in circulating blood after active stimulation versus sham stimulation within each group |
| Biomarkers of inflammation (tumor necrosis factor (TNF), and interleukin (IL)-1B and IL-6) in circulating whole blood stimulated ex vivo with lipopolysaccharide (LPS) | From collection up to 240 minutes, assessed upon receipt of assay results (up to one month) | Mean inflammation biomarker levels in LPS-stimulated whole blood after active stimulation versus sham stimulation within each group |
Countries
United States
Outcome results
None listed