A Study of Ear Nerve Stimulation to Treat Eye Inflammation

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07831876
Phase
PHASE1
Status
Recruiting

Conditions

  • Crystalline Lens; Chalcosis
  • Intraocular Lens Complication
  • Ocular Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Sep 9, 2026
Status verified
Sep 2026
Primary completion
Sep 9, 2028
Completion
Sep 9, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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

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 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Consent Only)Basking RidgeNew Jersey07920
Jasmine Francis, MD
212-639-7266
Memorial Sloan Kettering Monmouth (Consent only)MiddletownNew Jersey07748
Jasmine Francis, MD
212-639-7266
Memorial Sloan Kettering Bergen (Consent Only)MontvaleNew Jersey07645
Jasmine Francis, MD
212-639-7266
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)CommackNew York11725
Jasmine Francis, MD
212-639-7266
Memorial Sloan Kettering Westchester (Consent Only)HarrisonNew York10604
Jasmine Francis, MD
212-639-7266
Memorial Sloan Kettering Cancer Center (All Protocol Activites)New YorkNew York10065
Jasmine Francis, MD
212-639-7266
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)UniondaleNew York11553
Jasmine Francis, MD
212-639-7266

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