rTMS vs Propranolol in Prevention of Episodic Migraine: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- At 3 month, clinical outcome/ response and cGRP levels will be assessed of every patient and will be correlated with headache severity, intensity, frequency and duration.
研究概览
简要总结
Migraine ranks as the leading cause of years lived with disability in people younger than 50 years of age. various treatment and preventive therapies have been proposed till date for migraine. Here we are studying the comparison of rTMS with standard established medical therapy in patients with Episodic migraine. rTMS is an established add-on treatment modality along with drug therapy in migraine patients, but it is yet to be studied as an independent preventive and treatment modality. Patients will be enrolled from in patient as well as out patient department of neurology, banaras hindu university. This will be a randomised placebo controlled blinded trial in which 2 study arms will be assigned after proper randomisation in which one arm will be given tab propranolol with the sham of rTMS and the other arm will be given rTMS as the therapy along with placebo of propranolol. Baseline CGRP levels will also be compared with the after intervention values (3 months). various tools will be applied to know the severity of the illness like MIDAS, HIT questionnaire, migraine disability index done before the intervention and 3 months after the inytervention. predetermined frequency of rTMS pulse will be given to the patients, a total of 3 sessions/month for 3 months will be given. rTMS is yet to be proven as an independent modality in prevention of episodic migraine, this study and will be helpful for the patients who are suffering from episodic migraine and will serve a way for further studies in this field.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •In this prospective follow up study, we will enroll patients with Episodic migraine as per ICHD-3 criteria and satisfying age criteria will fall between 18 years and 55 years.Patients who are already taking medications for migraine and having washout period of atleast 1 month.Patients residing within the radius of 5 kms from the centre who can come for follow up.
排除标准
- •Patients with major psychiatric or neurological disease (stroke, epilepsy, head injury or tumor), malignancy, liver, or kidney failure, on migraine prophylaxis in the last 2 weeks or on immunotherapy, Patients with hypertension, cardiac diseases, bronchial asthma uncontrolled diabetes, bleeding disorders, or pregnancy, any contraindication to propranolol will also be excluded.
- •Those unwilling to give consent will be excluded.
结局指标
主要结局
At 3 month, clinical outcome/ response and cGRP levels will be assessed of every patient and will be correlated with headache severity, intensity, frequency and duration.
时间窗: At 3 month, clinical outcome/ response and cGRP levels will be assessed of every patient and will be correlated with headache severity, intensity, frequency and duration. | The primary outcome will be ≥ 50% reduction in headache days. | The secondary outcomes will be the reduction in severity, number of abortive medications, and side effects. | The exact frequency of headache, VAS score, and number of abortive medications will also be evaluated in both groups.
The primary outcome will be ≥ 50% reduction in headache days.
时间窗: At 3 month, clinical outcome/ response and cGRP levels will be assessed of every patient and will be correlated with headache severity, intensity, frequency and duration. | The primary outcome will be ≥ 50% reduction in headache days. | The secondary outcomes will be the reduction in severity, number of abortive medications, and side effects. | The exact frequency of headache, VAS score, and number of abortive medications will also be evaluated in both groups.
次要结局
- The secondary outcomes will be the reduction in severity, number of abortive medications, and side effects.(The exact frequency of headache, VAS score, and number of abortive medications will also be evaluated in both groups.)
研究者
Dr Deepika Joshi
BHU varanasi