Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Biomarker of hemostasis (tissue anti-thrombin (TAT) complex) in blood shed from fingerstick
研究概览
简要总结
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):
- Group 1: Sham taVNS followed by active taVNS
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is between 18 and 65 years of age
- •Participant is English proficient
- •Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
排除标准
- •Participant has a history of thrombocytopenia (platelet count <100k)
- •Participant has reported coagulopathy (elevated prothrombin time (PT), elevated partial thromboplastin time (PTT), elevated activated clotting time (ACT))
- •Participant has internal bleeding, external bleeding, easy bruising
- •Participant has a history of abnormal bleeding or blood disorder, including anemia or anemia-related disorders
- •Participant has a history of coagulopathy, including hemophilia, stroke, pulmonary embolism, myocardial infarction, or deep vein thromboses
- •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
- •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
- •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
- •Participant has consumed caffeine within the past 12 hours
- •Participant has received a blood transfusion within 30 days prior to study
- •Participant has a history of epileptic seizures
- •Participant has a history of neurologic diseases or traumatic brain injury
- •Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators)
- •Participant has abnormal ear anatomy or ear infection present
- •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
- •Females who are pregnant, lactating or menstruating
- •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
结局指标
主要结局
Biomarker of hemostasis (tissue anti-thrombin (TAT) complex) in blood shed from fingerstick
时间窗: 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
时间窗: 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)
时间窗: 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
次要结局
未报告次要终点