Recruiting

Phase 1

taVNSA Study of Ear Nerve Stimulation to Treat Eye Inflammation

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07831876

Conditions

Ocular Inflammation

Crystalline Lens; Chalcosis

Intraocular Lens Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cymbathera One System

Study Details

Brief summary:

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.

Conditions

Ocular Inflammation

Crystalline Lens; Chalcosis

Intraocular Lens Complication

Study ID

NCT07831876

Start date

Sep 9, 2026

Status verified date

Sep, 2026

Completion date

Sep 9, 2028

Anticipated

Primary completion date

Sep 9, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Inflammatory Ocular Surface Group

Participants will use the Cymbathera One System transcutaneous electrical stimulation

experimental: Intra/subretinal fluid group

Participants will use the Cymbathera One System transcutaneous electrical stimulation

Interventions

Cymbathera One System

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

Primary outcome measure

Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease. [ Time Frame: 1 year ]
Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with intra/subretinal fluid [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Jasmine Francis, MD

212-639-7266 francij1@mskcc.org

Daniel Kowalsky Moskaliuk, OD

212-639-3246 kowalsd1@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Jasmine Francis, MD

212-639-7266

Memorial Sloan Kettering Monmouth (Consent only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Jasmine Francis, MD

212-639-7266

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Jasmine Francis, MD

212-639-7266

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)

Recruiting

Commack, New York, United States, 11725

Contacts

Jasmine Francis, MD

212-639-7266

Memorial Sloan Kettering Westchester (Consent Only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Jasmine Francis, MD

212-639-7266

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Jasmine Francis, MD

212-639-7266

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Jasmine Francis, MD

212-639-7266

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

Ocular Inflammation
Ocular inflammatory condition
intraretinal fluid
subretinal fluid
natural crystalline lens
intraocular lens
Cymbathera One System
Memorial Sloan Kettering Cancer Center
26-317

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.