Ear nerve stimulation to help eye inflammation

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 Phase 1 interventional trial tests the Cymbathera One System, a device that delivers mild transcutaneous auricular vagus nerve stimulation (taVNS) to people with ocular inflammation. Eligible participants include adults with intra/subretinal fluid or inflammatory ocular surface disease in at least one eye and those who can complete visits at similar times of day. Imaging requirements for the intra/subretinal fluid group include dilated pupils and a viewable retina. Participants with active infection, implanted electronic devices, skin conditions at the stimulation site, or certain psychiatric issues are excluded. The study is led by Memorial Sloan Kettering Cancer Center with several consent-only sites in New Jersey.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Ocular inflammatory condition-specifically, at least 1 eye with intra/subretinal fluid or both eyes with an inflammatory ocular surface condition
* Able to attend all study visits at approximately the same time of day (within a 3-h window)

For participants in the intra/subretinal fluid group:

* The presence of a natural crystalline lens or intraocular lens
* Pupils that can dilate to at least 3 mm in the study eye(s)
* The absence of opaque natural crystalline lenses or the presence of any ocular disease that prevents the view of the retina for imaging

Exclusion Criteria:

* Having or exhibiting any of the following:

  * Evidence of active infection
  * Chronically implanted electronic medical device, including pacemakers, defibrillators, cochlear implants, spinal stimulators, and vagus nerve stimulators
  * Evidence of any skin condition at the stimulation site
  * Untreated or poorly controlled psychiatric illness
  * Evidence of significant neurological conditions, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, seizure, stroke, and dementia
  * Low blood pressure, bradycardia, or hypoglycemia
  * History of bleeding disorders, including sickle cell anemia, anemia syndromes, monocytosis, and thrombocytopenia
  * History of vagotomy
  * History of partial or complete splenectomy
  * History of HIV infection or AIDS
  * History of recurrent vasovagal syncope episodes
* Receipt of any of the following medications within 1 week of the first visit:

  * Anticholinergic (Benadryl)
  * Antihypertensive (α-methyldopa)
  * Epinephrine-related drugs, norepinephrine-related drugs, and drugs that stimulate release of epinephrine and/or norepinephrine (Micronefrin, Asthmanefrin)
  * Alpha and/or beta adrenoceptor blocking agents
  * Antiseizure medications
  * Other medications, supplements, etc. that may interfere with the study results
* Substance abuse (alcoholism or other) problem
* Consumption of alcohol within 1 day of a study visit
* Currently using or have used recreational drugs, tobacco, and/or nicotine products within 1 week of the first visit

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Consent Only)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Consent only)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Consent Only)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Consent Only)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jasmine Francis, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jasmine Francis, MD
• Email: francij1@mskcc.org
• Phone: 212-639-7266

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.