Clinical trial · Interventional
A Study of Ear Nerve Stimulation to Treat Eye Inflammation
Assessment of Transcutaneous Auricular Vagus Nerve Stimulation for Ocular Inflammatory Conditions
NCT07831876CI-TRIAL-00126499recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Crystalline Lens; Chalcosis | — | UNRESOLVED | — |
| Intraocular Lens Complication | — | UNRESOLVED | — |
| Ocular Inflammation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cymbathera One System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Inflammatory Ocular Surface Group
- description
- Participants will use the Cymbathera One System transcutaneous electrical stimulation
- interventionNames
- Device: Cymbathera One System
- type
- EXPERIMENTAL
- label
- Intra/subretinal fluid group
- description
- Participants will use the Cymbathera One System transcutaneous electrical stimulation
- interventionNames
- Device: Cymbathera One System
Primary outcomes (2)
- measure
- Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.