HemostasisHHSNCT05977946
Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects
A study testing Volta System in people with Hemostasis and Blood Biomarkers, run by Spark Biomedical, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemostasis, Blood Biomarkers
- What is being tested?
- Volta System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Feinstein Institutes for Medical Research
Manhasset, New York, 11030
About this study
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.
- Conditions
- Hemostasis, Blood Biomarkers
- Being tested
- Volta System
- Keywords
- Transcutaneous auricular neurostimulation, Transcutaneous auricular vagus nerve stimulation, Blood biomarkers, Neurostimulation, Healthy human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volta SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Experimental | Not described Receives: Device: Volta System |
| Transcutaneous Auricular Neurostimulation (tAN) | Experimental | Not described Receives: Device: Volta System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: From collection up to 240 minutes, assessed upon receipt of assay results (up to one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start31 Oct 2023
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spark Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977946
- Sponsor's protocol ID
- 5L-BLD-03
- Other IDs
- 23-0265
- Acronym
- HHS
- Status last verified
- Apr 2025
- First submitted
- 14 Jul 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Huston JM, Bravo-Iniguez CE, Papoin J, Ahmad M, Le B, Mirro I, McWade M, Benner C, Covalin A, Czura CJ, Khodaparast N, Blanc L. 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. Bioelectron Med. 2026 Jun 5;12(1):14. doi: 10.1186/s42234-026-00208-w.
PubMed 42243989
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT05977946
- Acronym / sponsor ID
- HHS / 5L-BLD-03
- Conditions
- Hemostasis, Blood Biomarkers
- Keywords
- Transcutaneous auricular neurostimulation, Transcutaneous auricular vagus nerve stimulation, Blood biomarkers, Neurostimulation, Healthy human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Experimental | Device: Volta System |
| Transcutaneous Auricular Neurostimulation (tAN) | Experimental | Device: Volta System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volta SystemThe 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). | Device | Transcutaneous Auricular Neurostimulation (tAN), Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
Primary outcome
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
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)
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
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)
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Derived from this study: PubMed 42243989Huston JM, Bravo-Iniguez CE, Papoin J, Ahmad M, Le B, Mirro I, McWade M, Benner C, Covalin A, Czura CJ, Khodaparast N, Blanc L. 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. Bioelectron Med. 2026 Jun 5;12(1):14. doi: 10.1186/s42234-026-00208-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volta System in people with Hemostasis and Blood Biomarkers, run by Spark Biomedical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05977946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.