NCT05977946 (HHS) is a NA clinical trial of Volta System in Hemostasis, sponsored by Spark Biomedical, Inc..

Who is sponsoring NCT05977946?

NCT05977946 is sponsored by Spark Biomedical, Inc..

What drugs are being tested in NCT05977946?

Interventions in NCT05977946: Volta System.

What condition does NCT05977946 study?

NCT05977946 studies Hemostasis, Blood Biomarkers.

Is NCT05977946 still recruiting?

NCT05977946 is currently completed. Last updated 9 April 2025.

Last reviewed 2025-04-09 · How we verify

NCT05977946: HHS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 9 April 2025

What this trial tests

NA trial testing Volta System in Hemostasis in 25 participants. Completed in 6 August 2024.

Timeline

31 October 2023

Primary endpoint
6 August 2024

6 August 2024

Quick facts

Lead sponsor	Spark Biomedical, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	25
Start date	31 October 2023
Primary completion	6 August 2024
Estimated completion	6 August 2024
Sites	1 location across United States

Drugs / interventions tested

Volta System

Conditions studied

Hemostasis — all drugs for Hemostasis →
Blood Biomarkers — all drugs for Blood Biomarkers →

Sponsor

Spark Biomedical, Inc.

Who can join

Adults 18 to 65, any sex, with Hemostasis or Blood Biomarkers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Transcutaneous auricular neurostimulation to reduce heavy menstrual bleeding in women with and without von Willebrand disease.
Czura CJ, Weyand AC, Baldwin MK, Recht M, et al · · 2025 · cited 2× · PMID 41133152 · DOI 10.3389/fmed.2025.1664433
Effects of transcutaneous auricular vagus nerve stimulation or combined vagal and trigeminal nerve stimulation on platelet function and laboratory hemostasis parameters in healthy human subjects.
Huston JM, Bravo-Iñiguez CE, Papoin J, Ahmad M, et al · · 2026 · PMID 42243989 · DOI 10.1186/s42234-026-00208-w
A novel transcutaneous auricular neurostimulation electrode configuration for treatment of heavy menstrual bleeding: an open-label trial.
Czura CJ, Weyand AC, Baldwin MK, Recht M, et al · · 2026 · PMID 41933398 · DOI 10.1186/s42234-026-00203-1

Verify or expand the search:

Other trials of Volta System

Trials testing the same drug.

NCT06814028 — Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial · NA · completed
NCT06064851 — Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von · NA · completed

Other recruiting trials for Hemostasis

Currently open trials in the same condition.

NCT06664788 — A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery · NA · recruiting
NCT03430609 — Ovarian Function After Use of Various Hemostatic Techniques During Treatment for Endometrioma · NA · active not recruiting

Other Spark Biomedical, Inc. trials

Trials by the same sponsor.

NCT07326722 — Delivering tAN to Reduce HMB: The LUNA Study · NA · recruiting
NCT07281261 — tAN for Substance Use Disorder · NA · recruiting
NCT07109349 — tAN for First Responders · NA · recruiting
NCT06487533 — Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder · recruiting
NCT06814028 — Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05977946 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Spark Biomedical, Inc.
Last refreshed: 9 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05977946.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing