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

NCT05977946 | Completed FDA Device

• 2 other identifiers: 5L-BLD-0323-0265
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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. 1.Group 1: Sham taVNS followed by active taVNS
2. 2.Group 2: Sham tAN followed by active tAN

Conditions

Hemostasis; Blood Biomarkers

Keywords

Transcutaneous auricular neurostimulation; Transcutaneous auricular vagus nerve stimulation; Blood biomarkers; Neurostimulation; Healthy human

Outcome Measures

Primary Outcomes (6)

• Biomarker of hemostasis (tissue anti-thrombin (TAT) complex) in blood shed from fingerstick

  Mean TAT levels in shed blood after active stimulation versus sham stimulation within each group

  From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)

• Biomarker of hemostasis (tissue anti-thrombin (TAT) complex) in blood shed from fingerstick

  Percent change in TAT levels in shed blood after active stimulation between groups (taVNS vs tAN)

  From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)

• Biomarkers of hemostasis (TAT complex, D-dimer, viscoelasticity, coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) in circulating blood

  Mean coagulation biomarker levels in circulating blood after active stimulation versus sham stimulation within each group

  From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)

• Biomarkers of hemostasis (TAT complex, D-dimer, viscoelasticity, coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) in circulating blood

  Percent change in coagulation biomarker levels in circulating blood after active stimulation between groups ( taVNS vs tAN)

  From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)

• Biomarkers of inflammation (tumor necrosis factor (TNF), and interleukin (IL)-1B and IL-6) in circulating whole blood stimulated ex vivo with lipopolysaccharide (LPS)

  Mean inflammation biomarker levels in LPS-stimulated whole blood after active stimulation versus sham stimulation within each group

  From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)

• Biomarkers of inflammation (tumor necrosis factor (TNF), and interleukin (IL)-1B and IL-6) in circulating whole blood stimulated ex vivo with lipopolysaccharide (LPS)

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

  From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)

Study Arms (2)

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

EXPERIMENTAL

Device: Volta System

Transcutaneous Auricular Neurostimulation (tAN)

EXPERIMENTAL

Device: Volta System

Interventions

Volta System DEVICE

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).

Transcutaneous Auricular Neurostimulation (tAN); Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spark Biomedical, Inc.: lead
• Northwell Health: collaborator

Study Sites (1)

The Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 7, 2023
• Study Start: October 31, 2023
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (1)