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NCT Number: NCT07831876

A Study of Ear Nerve Stimulation to Treat Eye Inflammation

The purpose of this study to find out whether a device that delivers mild electrical stimulation to the ear (transcutaneous auricular vagus nerve stimulation, or taVNS) can reduce inflammation in the eye in people with ocular inflammatory conditions. The device is called the Cymbathera One System.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering at Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cymbathera One System

Device

Cymbathera One System provides transcutaneous electrical stimulation to the auricular branch of the vagus nerve

Primary outcomes

  1. Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.

    Time frame: 1 year

    The primary objective is to estimate changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.

  2. Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with intra/subretinal fluid

    Time frame: 1 year

    The primary objective is to estimate changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with intra/subretinal fluid.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Assessment of Transcutaneous Auricular Vagus Nerve Stimulation for Ocular Inflammatory Conditions

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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