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

Hemostasis Clinical Trial

— HHS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977946
• Other study ID #: 5L-BLD-03
• Secondary ID: 23-0265
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2024
• Source: Spark Biomedical, Inc.
• Contact: Maaryj Ahmad
• Phone: (516) 562-1505
• Email: mahmad11[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Participant is between 18 and 65 years of age

2. Participant is English proficient

3. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

1. Participant has a history of thrombocytopenia (platelet count <100k)

2. Participant has reported coagulopathy (elevated prothrombin time (PT), elevated partial thromboplastin time (PTT), elevated activated clotting time (ACT))

3. Participant has internal bleeding, external bleeding, easy bruising

4. Participant has a history of abnormal bleeding or blood disorder, including anemia or anemia-related disorders

5. Participant has a history of coagulopathy, including hemophilia, stroke, pulmonary embolism, myocardial infarction, or deep vein thromboses

6. 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

7. 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

8. 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

9. Participant has consumed caffeine within the past 12 hours

10. Participant has received a blood transfusion within 30 days prior to study

11. Participant has a history of epileptic seizures

12. Participant has a history of neurologic diseases or traumatic brain injury

13. Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators)

14. Participant has abnormal ear anatomy or ear infection present

15. 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

16. Females who are pregnant, lactating or menstruating

17. 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

Related Conditions & MeSH terms

• Blood Biomarkers
• Hemostasis

Intervention

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).

Locations

Country	Name	City	State
United States	The Feinstein Institutes for Medical Research	Manhasset	New York

Sponsors (3)

Lead Sponsor	Collaborator
Five Liters, Inc.	Northwell Health, The Feinstein Institutes for Medical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)