跳至主要内容
临床试验/CTRI/2023/12/060797
CTRI/2023/12/060797尚未招募2/3 期

To study the Efficacy of repetitive transcranial magnetic stimulation (rTMS)in chronic migraine with vestibular symptoms, An open labelled randomized sham control study.

AIIMS Bhunaneswar1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年1月6日最近更新:

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

发起方
AIIMS Bhunaneswar
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Karnati Uday Kumar

aiims bhubaneswar

研究点 (1)

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