Combined Effects of rTMS and Botulinum Toxin in Benign Essential Blepharospasm: A Novel Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in JRS Frequency Score
研究概览
简要总结
Benign essential blepharospasm (BEB) is a functionally disabling focal dystonia. Botulinum neurotoxin (BoNT) therapy is suboptimal in many BEB patients. Repetitious transcranial magnetic stimulation (rTMS) therapy is a promising noninvasive therapy and has shown positive benefits in BEB. rTMS therapy can be easily combined with BoNT injections to enhance the effects of BoNT in BEB.
详细描述
A two week course of rTMS therapy to achieve sustained benefits will be employed. With standard BoNT treatment, the peak-dose benefits are seen at about 4-6 weeks after the administration of injections. rTMS will be introduced during this peak-dose period (about 6 weeks after BoNT or T1).The effects of combined therapy at about 10 weeks after BoNT injections (T2) and at about 12 weeks after BoNT injections (T3) will be examined along with the physiological effects at these time points.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects diagnosed with blepharospasm or cranio-cervical dystonia who receive BoNT therapy at the Center for Movement Disorders will be approached. The investigators will enroll only those subjects who report experiencing positive benefits with BoNT but lasting about 10 weeks or less.
排除标准
- •pregnancy
- •active seizure disorder
- •significant cognitive impairment
- •exposure to neuroleptics
- •presence of a metallic body such as pacemaker, implants, prosthesis, artificial limb or joint, shunt, metal rods and hearing aid.
结局指标
主要结局
Change in JRS Frequency Score
时间窗: 2 weeks after rTMS
The change in the score of the Jankovic Rating Scale subscore for frequency. Rated on a 5-point scale (0-4), where a higher score indicates higher frequency of forced blinks in blepharospasm.
Change in Number of Sustained Forced Eye Blinks
时间窗: 2 weeks after rTMS
A video recording (5 minutes) was scored by two blinded neurologists to count the number of sustained forced eye-blinks.
Change in JRS Severity Score
时间窗: 2 weeks after rTMS
The change in the score of the Jankovic Rating Scale subscore for severity. Rated on a 5-point scale (0-4), where a higher score indicates higher severity of blepharospasm.
Change in Duration of Forced Blinks
时间窗: 2 weeks after rTMS
A video recording (5 minutes) was scored by two blinded neurologists to count the duration of sustained forced eye-blinks.
次要结局
- Change in CDQ-24 QOL Score(2 weeks after rTMS)
- Change in CDQ-24 ADL Subscore(2 weeks after rTMS)
- Change in Social Subscale of CDQ-24(2 weeks after rTMS)