Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects

Spark Biomedical, Inc.25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Hemostasis Blood Biomarkers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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