Assessment of Transcutaneous Auricular Vagus Nerve Stimulation for Ocular Inflammatory Conditions
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Inflammatory Ocular Surface Group
Participants will use the Cymbathera One System transcutaneous electrical stimulation
干预措施: Cymbathera One System (Device)
Intra/subretinal fluid group
Participants will use the Cymbathera One System transcutaneous electrical stimulation
干预措施: Cymbathera One System (Device)
结局指标
主要结局
Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点