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

Sponsor

Five Liters, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05977946

Collaborator

Northwell Health (Other), The Feinstein Institutes for Medical Research (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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):

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.

Condition or Disease	Intervention/Treatment	Phase
Hemostasis Blood Biomarkers	Device: Volta System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)	Device: Volta System The Volta System is a wearable, battery-operated, neurostimulation system designed to deliver tAN or taVNS.
Experimental: Transcutaneous Auricular Neurostimulation (tAN)	Device: Volta System The Volta System is a wearable, battery-operated, neurostimulation system designed to deliver tAN or taVNS.

Arm

Intervention/Treatment

Experimental: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Device: Volta System

The Volta System is a wearable, battery-operated, neurostimulation system designed to deliver tAN or taVNS.

Experimental: Transcutaneous Auricular Neurostimulation (tAN)

Device: Volta System

The Volta System is a wearable, battery-operated, neurostimulation system designed to deliver tAN or taVNS.

Outcome Measures

Primary Outcome Measures

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
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)]
Percent change in TAT levels in shed blood after active stimulation between groups (taVNS vs tAN)
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 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)]
Percent change in coagulation biomarker levels in circulating blood after active stimulation between groups ( taVNS vs tAN)
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
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)]
Percent change in inflammation biomarker levels in LPS-stimulated whole blood after active stimulation between groups (taVNS vs tAN)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Feinstein Institutes for Medical Research	Manhasset	New York	United States	11030

Sponsors and Collaborators

Five Liters, Inc.
Northwell Health
The Feinstein Institutes for Medical Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Five Liters, Inc.

ClinicalTrials.gov Identifier:

NCT05977946

Other Study ID Numbers:

5L-BLD-03
23-0265

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Five Liters, Inc.

Transcutaneous auricular neurostimulation

Transcutaneous auricular vagus nerve stimulation

Blood biomarkers

Neurostimulation

Healthy human

Study Results

No Results Posted as of Aug 7, 2023