Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in Elevation of Corner of Mouth Over 14 weeks
研究概览
简要总结
Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial paralysis causes physical, social and emotional problems. Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated, causing them to contract This study is designed to help patients with facial nerve weakness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.
排除标准
- •History of epilepsy or seizures.
- •Individuals with metal orthopedic implants in the mouth (e.g. plates or screws).
- •Individuals suffering from fibromyalgia.
- •Individuals currently receiving any form of transcranial brain stimulation (e.g. rTMS, ECT, or MST).
研究组 & 干预措施
Standard of Care Group
No FES
Assessments will be taken at the same intervals as the interventions group.
Acute Facial Nerve Injury with Intact Facial Nerve
40 sessions of FES (in a 14 week period)
Assessments will be taken during the beginning, middle, and end of each study arm.
干预措施: Application of FES to the Face (Other)
Facial Nerve Grafting After Surgical Excision
40 sessions of FES (in a 14 week period)
Assessments will be taken during the beginning, middle, and end of each study arm.
干预措施: Application of FES to the Face (Other)
结局指标
主要结局
Change in Elevation of Corner of Mouth Over 14 weeks
时间窗: Measured at week 0, 7 and 14
Change in ability to raise corner of mouth, measured in mm
FaCE Questionnaire
时间窗: Administered at week 0, 7 and 14
Patient-based instrument to measure both facial impairment and disability. This will be used to identify patient's perceived change in facial impairment for the duration of the study period.
Change in Lagophthalmos Over 14 weeks
时间窗: Measured at week 0, 7 and 14
Change in ability to close eyelids, measured in mm
Change House-Brackmann Scale Measurement Over 14 weeks
时间窗: Measured at week 0, 7 and 14
The House-Brackmann facial nerve grading scale is a measure of facial nerve impairment. The scale ranges from values 1 to 6, with larger values indicating greater facial nerve impairment.
Change in Facial Movements Over 14 weeks
时间窗: Measured at week 0, 7 and 14
A video will be taken of the patient undergoing standard facial movements
Study Interview
时间窗: Administered at week 0, 7 and 14
A structured interview questionnaire administered by a study team member to identify any changes to the therapy that may be needed before further studies are conducted
次要结局
未报告次要终点