Artificial Eye Blinking Stimulation Following Paralysis of the Facial Nerve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Eyelid closure - Partial or complete closure
研究概览
简要总结
Artificial eye blinking stimulation following damage to the facial nerve. Group 1 - Patients with a persistent unilateral facial paralysis (palsy) that underwent an operation for facial reanimation Group 2 - Patients with temporary unilateral facial paralysis, secondary to unilateral Bell's palsy.
Primary objective: To evaluate whether the Neurotigger device can elicit a complete or a partial eyelid closure of the affected eye.
Secondary objective: To optimize the location of the Neurotrigger's electrodes, and define the level of the pain generated, if any, during device implementation and stimulation, as well as the method for the personal adjustment of the precise pattern of stimulation (strength, intensity, other features) to achieve eye blinking for different patients.
详细描述
The study will involve two groups:
Group 1: Patients with a continuous unilateral facial paralysis that underwent an operation for facial reanimation will be enrolled at least one year after the operation according to review of medical records of the Department of plastic surgery.
Group 2: Patients with temporary unilateral facial paralysis secondary to Bell's palsy as was identified in the admission to the Hospital Department of Plastic Surgery or to the Department of Ear, Nose and Throat.
After being identified eligible to participate in the study, the patients will be invited to join the study, sign on the written informed consent, and their demographic and medical history will be recorded.
Patients identified to belong to these study groups in other hospitals may join the study, after pre-evaluation and medical record analysis by the study Principle Investigator (PI)/Co-PI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The Principle Investigators of the Clinical study will code the patients by the study enrolment number provided at the day of enrolment and is not disclosed to the sponsor
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
- •Patients who meet ALL of the following criteria will be eligible for enrollment into this study:
- •All patients
- •Male or female above 18 years of age inclusive
- •All patients will have to agree to provide a written informed consent, Fully understand all elements of and actually sign and date the written Institutional Review Board (IRB) approved informed consent before initiation of protocol-specified procedures;
- •Willing to provide medical and demographic records of their facial paralysis, the consequences of the paralysis and general medical history.
- •5. Patients who comply with the definition of continuous existing unilateral facial paralysis and who underwent an operation for facial reanimation at least one year prior to enrollment
- •5. Patients who comply with the definition of temporary unilateral facial paralysis secondary to Bell's palsy up to 2 years from the event.
- •Second Phase
- •All initial inclusion criteria will be as in phase 1
- •Enrollment will be dependent on having a partner willing and capable to offer the six days a week daily support in placing the Neurotrigger simulator and closing eye at night time for a period of 3 weeks.
排除标准
- •Patients with chronic facial paralysis and secondary established damage to the eye occurring prior to enrollment, Who did not undergo facial reanimation surgery.
- •Patients with psychiatric, addictive, or any other disorder that compromises ability to give genuine informed consent for participation in this study.
- •Patients suffering from any skin condition that will prevent effective attachment of the electrodes, including but not limited to allergy to any of the components of the skin electrode.
- •Woman who is pregnant (positive pregnancy test)
- •Woman who is nursing
- •Unwillingness or inability to follow the procedures outlined in the protocol.
研究组 & 干预措施
Single use and continuous use
Patients with a continuous unilateral facial paralysis that underwent an operation for facial reanimation will be enrolled at least one year after the operation according to review of medical records of the Department of plastic surgery.
Patients with temporary unilateral facial paralysis secondary to Bell's palsy as was identified in the admission to the Hospital Department of Plastic Surgery or to the Department of Ear, Nose and Throat.
干预措施: Neurotrigger eye blinking stimulator (Device)
结局指标
主要结局
Eyelid closure - Partial or complete closure
时间窗: 3 hours
Partial or complete eye closure. The results will be detailed in a data table which will include details of the number of participants, affiliation to a research group and level of eyelid closure.
次要结局
- Stage 2 only - Improving quality of life - The measurement will be performed by filling out a Quality of Life Questionnaire.(three weeks)