To study the Efficacy of repetitive transcranial magnetic stimulation (rTMS)in chronic migraine with vestibular symptoms, An open labelled randomized sham control study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 1.The primary outcome measures were defined at 1 month as
研究概览
简要总结
Migraine is a disease that stays lifelong . It needs abortive
treatment for acute headache and prophylactic treatment for recurrent headache. Experimental and human
research have shown that abnormality of trigeminovascular
system, brainstem and cerebral cortex are involved in migraine pathogenesis. It has been shown experimental studies that single pulse of transcranial magnetic stimulation (TMS) can
interrupt cortical excitability in depression(6,7) . This finding has opened the gate for evaluating the TMS for acute migraine treatment.High-frequency rTMS may increase the cortical activity found in
controlling pain(8) or decrease cortical excitation(9). So this can be used in migraine prophylaxis. Repetitive Transcranial magnetic stimulation (rTMS) is a painless, easy to deliver, affordable neurophysiological technique widely used as treatment. It produces sub or suprathreshold currents by electromagnetic induction, in the cortex. There are two types of rTMS modalities are available. One is high-frequency (HF-rTMS) stimulation (>1 Hz).It increases excitability of motor cortex of the stimulated area. Second is low-frequency (LF-rTMS) stimulation (⩽1 Hz) .It usually causes a reduction in cortical excitation .Coil position during rTMS session is defined by the area where motor threshold (MT) is recorded. MT is defined as lowest transcranial magnetic stimulation intensity needed to produce a motor evoke potential (MEP) of amplitude >50µv in at least 6 of 10 trials. The rTMS role has been proven in other disease like depression, migraine prophylaxis with minimal side effects. Various studies has shown mixed results about rTMS role in migraine prophylaxis. In 27 migraine patients who are given Low-frequency rTMS shown improvement of headache frequency but without significant difference with respect to sham stimulation group(9). There are two studies with High-frequency rTMS. A study, involving 11 migraine patients , with 6 patients receiving 400 pulses of rTMS at 20 Hz at 90 % of MT for 12 sessions and five patients received sham stimulation(8). Frequency of headache, rescue pill intake decreased significantly. In rTMS
group this effect persisted for 8 weeks . This effect of rTMS
was not shown in other studies. Low-frequency rTMS has was not effective when two trains of one Hz ,500 pulses was given for
five contineous days(9) . An open-labeled trial shown ten Hz
rTMS consisting of 600 pulses in ten trains on alternate
days for three days was given(10). This trial shown efficacy in decreasing headache frequency by more than 50 % among 80 % of patients. This benefit stayed for four weeks . These variability about effect of rTMS as prophylaxis in chronic migraine is needed to be addressed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •a)Patients fulfilling the diagnostic criteria of chronic migraine according to ICHD-3criteria , that is headaches on 15 days or more days per month in a patient with prior migraine history , with at least 8 days per month being migraine for at least 3 months .
- •b)Patients with chronic migraine with vestibular symptoms .
- •c)Adults of > 18 years of age.
排除标准
- •a)Patients with prior history of hearing loss ,non migranous vestibular symptoms , hearing aids , implants .
- •b)Patients with pregnancy,CLD,CKD,malignancy,severe hypertension, pacemaker or metallic implants, and history of seizures or structural brain lesions , advanced heart failure have been excluded .
结局指标
主要结局
1.The primary outcome measures were defined at 1 month as
时间窗: The primary outcome measures were defined at 1 month
follows:
时间窗: The primary outcome measures were defined at 1 month
a)Reduction in headache frequency by 50%
时间窗: The primary outcome measures were defined at 1 month
b)Improvement in severity on Visual Analogue
时间窗: The primary outcome measures were defined at 1 month
Scale (VAS) (0-100) by 50 %
时间窗: The primary outcome measures were defined at 1 month
c)Functional disability
时间窗: The primary outcome measures were defined at 1 month
d)Adverse events
时间窗: The primary outcome measures were defined at 1 month
e)Reduction of DHI score 50%
时间窗: The primary outcome measures were defined at 1 month
次要结局
- Secondary outcome will be(1. To study the assessment of VEMP)
研究者
Dr Karnati Uday Kumar
aiims bhubaneswar
