Clinical trial NCT05977946: Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects
Official title: Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemostasis
Blood Biomarkers
Keywords: Transcutaneous auricular neurostimulation
Transcutaneous auricular vagus nerve stimulation
Blood biomarkers
Neurostimulation
Healthy human
Lead sponsor: Spark Biomedical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Northwell Health
First posted: 2023-08-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Biomarker of hemostasis (tissue anti-thrombin (TAT) complex) in blood shed from fingerstick
timeFrame: From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)
measure: Biomarker of hemostasis (tissue anti-thrombin (TAT) complex) in blood shed from fingerstick
timeFrame: From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)
measure: Biomarkers of hemostasis (TAT complex, D-dimer, viscoelasticity, coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) in circulating blood
timeFrame: From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)
measure: Biomarkers of hemostasis (TAT complex, D-dimer, viscoelasticity, coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) in circulating blood
timeFrame: From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)
measure: Biomarkers of inflammation (tumor necrosis factor (TNF), and interleukin (IL)-1B and IL-6) in circulating whole blood stimulated ex vivo with lipopolysaccharide (LPS)
timeFrame: From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)
measure: Biomarkers of inflammation (tumor necrosis factor (TNF), and interleukin (IL)-1B and IL-6) in circulating whole blood stimulated ex vivo with lipopolysaccharide (LPS)
timeFrame: From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: The Feinstein Institutes for Medical Research
state: New York
Study officials:
References: