Vagustim taVNS: Testing a sham in adults for immune-related conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will randomize 20 adults to active Vagustim taVNS or sham stimulation for 10 minutes, with cytokine levels measured before treatment and two hours after. The goal is to validate the device’s sham method as an appropriate placebo for clinical trials. The trial uses a blinded investigator and an unblinded coordinator to preserve blinding during treatment. Blood samples will be analyzed to see if there are differences in circulating cytokines between groups. The device provides adjustable stimulation via in-ear or clip-on electrodes and communicates with an app.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Capable of giving informed consent or have an acceptable surrogate capable of giving consent on the participant's behalf.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

1. Participants or guardians who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
2. Any known inflammatory condition (e.g., SLE) or other chronic condition including kidney disease (exceptions: temporary urinary conditions, including urinary tract infection (UTI), microscopic hematuria, etc. )
3. History of cardiac disease (arrhythmias, structural/functional abnormalities).
4. Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants, or deep brain stimulators).
5. Chronic rash or skin breakdown of the left ear at the cymba concha.
6. Pregnancy or breast feeding.

Where it's running

• Cohen Children's Medical Center, Pediatric Nephrology
  New Hyde Park, New York, United States Recruiting

Study contacts

• Study coordinator: Christine Sethna, MD
• Email: csethna@northwell.edu
• Phone: 718-470-3491

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.