A Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Marginal reflex distance-1 (MRD-1)
研究概览
简要总结
Traumatic brain injury, stroke and other neurological conditions may result in weakness of the muscles that either open or close the eye. This is generally a result of impaired functioning of the oculomotor or facial cranial nerves. Current treatments to improve eye opening or closing are either invasive or largely ineffective. This study tests a noninvasive means of improving eyelid opening and closing by applying a previously demonstrated safe and effective neuromuscular electrical stimulation (NMES) intervention to the muscles controlling eyelid movement. Participants in this study will either receive the investigational NMES protocol 30 min per day for five days or a sham NMES for the same period. The primary outcome for this study is the participants' ability to open or close their affected eye. Secondary outcomes include additional measures of eye and corneal health.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants in treatment and sham group undergo all of the same procedures except a sham NMES treatment is provided to the control group. Only the treating clinician is aware of group allocation. The investigator and outcomes assessor are unaware of group allocation.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cranial nerve III (oculomotor nerve) and/or cranial nerve IV (facial nerve) palsy.
- •Able to read and communicate in English.
排除标准
- •Idiopathic onset of CN III and/or CN IV palsy.
- •Traumatic injury to the eye or eyelid.
- •Active wounds in the treatment area.
- •Presence of swelling or infection in or surrounding the affected eye.
- •Diminished sensation in the area to be treated.
结局指标
主要结局
Marginal reflex distance-1 (MRD-1)
时间窗: Within 1 week of last treatment session.
Measure of eyelid function for participants with CN III or CN VII palsy
Palpebral fissure height
时间窗: Within 1 week of last treatment session.
Measure of eyelid function for participants with CN III or CN VII palsy
次要结局
- Upper eyelid crease distance(Within 1 week of last treatment session.)
- World Health Organization Quality of Life - BREF (WHOQOL-BREF)(Within 1 week of last treatment session.)