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Vagus Nerve Stimulation for Healthy Adults (HHS Trial)

N/A

Recruiting

Research Sponsored by Five Liters, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is between 18 and 65 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from collection up to 240 minutes, assessed upon receipt of assay results (up to one month)

Awards & highlights

HHS Trial Summary

This trial tests how transcutaneous stimulation of the vagus nerve using two different types of devices affects healthy adults.

Who is the study for?

Healthy adults who speak English, aged 18-65, and can consent to the study may join. Excluded are those with clotting disorders, chronic tobacco or nicotine use in the last three months, bleeding issues, pregnant or lactating women, low platelet counts, blood disorders like anemia or hemophilia, recent transfusions or certain medications affecting blood clotting. Also excluded are individuals with pacemakers or similar devices, seizure history, neurological diseases or brain injuries.Check my eligibility

What is being tested?

The trial is testing a device called Volta System for its effects on blood biomarkers related to clotting. Participants will be randomly assigned to receive either sham (fake) stimulation followed by active transcutaneous auricular vagus nerve stimulation (taVNS), targeting specific nerves in the ear over a single session lasting 30 minutes.See study design

What are the potential side effects?

Potential side effects of taVNS include discomfort at the site of stimulation on the ear and mild headaches. Since this is non-invasive and used on healthy subjects for a short duration during this study phase; significant adverse events are not commonly expected.

HHS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

HHS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from collection up to 240 minutes, assessed upon receipt of assay results (up to one month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from collection up to 240 minutes, assessed upon receipt of assay results (up to one month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from collection up to 240 minutes, assessed upon receipt of assay results (up to one month) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

HHS Trial Design

2Treatment groups

Experimental Treatment

Group I: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Experimental Treatment1 Intervention

Group II: Transcutaneous Auricular Neurostimulation (tAN)Experimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Five Liters, Inc.Lead Sponsor

1 Previous Clinical Trials

10 Total Patients Enrolled

Northwell HealthOTHER

460 Previous Clinical Trials

471,013 Total Patients Enrolled

1 Trials studying Hemostasis

60 Patients Enrolled for Hemostasis

The Feinstein Institutes for Medical ResearchUNKNOWN

2 Previous Clinical Trials

223 Total Patients Enrolled

Media Library

Hemostasis Research Study Groups: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Transcutaneous Auricular Neurostimulation (tAN)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be an appropriate candidate for this medical research project?

"Candidates that are eligible for this clinical trial should be in a state of hemostasis and aged between 18 to 65. Currently, the team is recruiting 30 participants."

Answered by AI

Does this experiment have an age requirement of over 20 for participant eligibility?

"This clinical trial is seeking participants aged 18 and over, but younger than 65 years of age."

Answered by AI

Are there vacancies for potential participants in this scientific experiment?

"Based on the information from clinicaltrials.gov, this study is no longer actively recruiting participants. Published on August 1st 2023 and last updated two days later, there are currently six other trials that are in need of volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05977946.