Pilot Trial of Non-invasive Electrostimulation in Chronic Ocular Graft-vs-Host Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Efficacy of Electrostimulation (ES) Treatment.
研究概览
简要总结
This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.
详细描述
The trial is to test whether transcutaneous electrical stimulation (TES) may be an effective new type of non-invasive treatment for patients who are diagnosed with chronic ocular Graft-vs-Host Disease. Such a treatment can potentially decrease the need for the patients to apply eye drops frequently, repair the damage caused by chronic ocular Graft-vs-Host Disease, and improve the comfort of the eyes naturally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The principal investigator and the participants will be masked to treatment. The study staff setting up the device will be the only staff who will know the randomization.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic ocular graft vs. host disease (oGVHD) (ICCGVHD criteria probable or definite)
- •OSDI score of 22 or higher
- •NEI corneal staining score (or modified NEI score) of 2 or higher.
排除标准
- •Patients with any open wound on the eyelid.
- •Patient with any active cornea ulcer, dacryocystitis, hordeolum, filamentary keratitis, uveitis, retinal detachment, uncontrolled glaucoma or other active pathology per PI's discretion.
- •Patient with a pacemaker or ICD.
- •Patient currently pregnant or with a potential to be pregnant during the study.
- •Patient undergoing any ocular surgical procedure (including intravitreal injections) within the past 3 months.
- •Patient undergoing any systemic surgical procedures within 2 months.
- •Patient undergoing any non-surgical eyelid procedure such as punctal plugs or punctal cautery within 1 month of study initiation.
- •Patients on cytotoxic agents, drugs that inhibit peripheral nerve regeneration (i.e. Gabapentin, Nicotine), radiation therapy, or any other therapy per PI's discretion.
- •Patients undergoing immunosuppression regimen change within 1 month of study initiation and/or during the study period.
- •Patient who wears contact lens of any kind
研究组 & 干预措施
Electrostimulation
The experimental group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITH amplitude.
干预措施: Electrodes with Currents (Device)
Sham
The placebo group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITHOUT amplitude.
干预措施: Electrodes without Currents (Device)
结局指标
主要结局
Efficacy of Electrostimulation (ES) Treatment.
时间窗: 8 Weeks
To evaluate whether the use of electrostimulation (ES) over a course of 10 treatments (in 8 weeks) will ameliorate symptoms and signs of chronic ocular Graft-vs-Host Disease (oGVHD) and the effect on sub-basal corneal nerve regeneration.
次要结局
未报告次要终点
研究者
Zhonghui K. Luo, MD, PhD
Principal Investigator
Massachusetts Eye and Ear Infirmary