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Completed

NCT Number: NCT05977946

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

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.

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Key information

Conditions

Hemostasis Blood Biomarkers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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)

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

    Time frame: 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

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

    Time frame: 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)

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

    Time frame: 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

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Spark Biomedical, Inc.

Industry

Collaborators

  • Northwell Health

Registry information

Acronym: HHS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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