NCT07831876 · Memorial Sloan Kettering Cancer Center
A Study of Ear Nerve Stimulation to Treat Eye Inflammation
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Cymbathera One System
Cymbathera One System provides transcutaneous electrical stimulation to the auricular branch of the vagus nerve
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 21, 2026 · Source of record for eligibility and locations