Vagustim Device for Healthy Controls
What You Need to Know Before You Apply
What is the purpose of this trial?
Transcutaneous auricular vagus nerve stimulation (taVNS) has become a therapy of interest for treating chronic immune-medicated illnesses in adults and children. Vagustim™ taVNS devices are commercially available devices that have been used in clinical and non-clinical studies examining inflammatory conditions. Previous work of the investigative team has utilized TENS devices from Roscoe Medical to deliver stimulation. We aim to evaluate Vagustim™'s sham stimulation method as a placebo for clinical trials.
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 or older who can give consent and are willing to follow study procedures. People with heart problems, chronic inflammatory or kidney diseases, certain ear skin issues, implanted electronic devices, or those who are pregnant or breastfeeding cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time 10-minute taVNS or sham treatment with blood samples taken pre-treatment and 2 hours post-treatment
Follow-up
Participants are monitored for cytokine levels post-treatment to evaluate the feasibility of the sham methodology
What Are the Treatments Tested in This Trial?
Interventions
- Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Device
Trial Overview
The study is testing the Vagustim™ device that stimulates the vagus nerve through the ear. It aims to evaluate how well its sham (placebo) stimulation works in comparison to real stimulation among healthy volunteers.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Those who are randomized to the active treatment will receive vagus nerve stimulation for the full 10 minutes of their session.
Those who are randomized to the sham treatment will receive vagus nerve stimulation for 10 seconds at the beginning of the 10 minute treatment session.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
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