A Study of Ear Nerve Stimulation to Treat Eye Inflammation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
The presence of a natural crystalline lens or intraocular lens
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cymbathera One System
DeviceCymbathera One System provides transcutaneous electrical stimulation to the auricular branch of the vagus nerve
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Inflammatory Ocular Surface GroupExperimental treatment 1 intervention
Group B: Intra/subretinal fluid groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.
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.
Time frame
1 year2
Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with intra/subretinal fluid
The primary objective is to estimate changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with intra/subretinal fluid.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov