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

NCT05977946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

  • Hemostasis
  • Blood Biomarkers

Interventions

DEVICE

Volta System

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).

Sponsors & Collaborators

  • Northwell Health

    collaborator OTHER

  • Spark Biomedical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2024-08-06
Completion
2024-08-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05977946 on ClinicalTrials.gov