Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Sunnybrook facial grading scale
研究概览
简要总结
The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy
详细描述
Patients with severe synkinesis treated at Karolinska University Hospital with Botox injections with unsatisfying results are invited to participate in this study aiming to evaluate surgical neurotomy to synkinesis causing branches of the facial nerve.
Surgical procedure:
Small branches of the facial nerve are identified under microscopic magnification. Using a precise nerve stimulator the movement each nerve branch elicits is evaluated as normal or synkinetic. Pathological branches are then parted while normal functioning nerve branches are left intact.
Evaluation procedure:
Study participants are measured in a multimodal manner at 5 different time points during the study period; at study start, with and without Botox effect before surgery, and at 6 and 12 months after surgery. Evaluation methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Synkinesis following peripheral facial palsy
- •Sunnybrook score <61
- •Botox injections at least 3 times a year
- •Have received at least 3 Botox injections
- •Botox injections not satisfying treatment
- •Read and signed written consent
排除标准
- •Synkinesis since less than 2 years
- •Contractures in facial muscles
- •Other planned surgery in the face during study period
- •Uncontrolled hypertension
- •Diabetes mellitus
- •Pregnancy or breast feeding
- •Severe systemic disease (ASA 3-4)
结局指标
主要结局
Sunnybrook facial grading scale
时间窗: Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Improvement through less synkinesis and better voluntary movement
次要结局
- Neurophysiological examination, electromyography (EMG).(4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery)
- Number of Botox injections(Baseline, 12 months after surgery)
- Quality of life questionnaire(4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery)
- Side effects(Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery)
研究者
Rebecka Ohm
Birgit Stark, MD, associate professor
Karolinska University Hospital