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临床试验/CTRI/2024/03/064293
CTRI/2024/03/064293尚未招募4 期

To study the efficacy and impact on quality of life of repetitive transcranial magnetic stimulation in chronic migraine patients- A Randomised Open labelled study

Institute of Medical Sciences Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月31日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
50
试验地点
1
主要终点
To look for severity of headache reduction between both the groups

研究概览

简要总结

Headache is among one of the most common reasons to seek medical care at hospital. It may be debilitating to affect the quality of life and hamper the daily routine activities. Migraine is one of the primary headache disorders . In the Global Burden of Disease Study2010 (GBD2010), it was ranked as the third most prevalent disorder in the world. In GBD2015, it was ranked third–highest cause of disability worldwide in both males and females under the age of 50 years. Migraine that occurs on more than 15 days per month for 3 or more consecutive months is considered chronic migraine. Non invasive neuromodulation techniques are emerging as alternative or as adjunctive treatment in resistant headache disorders. Repetitive transcranial magnetic stimulation(rTMS) suppresses the cortical spreading depression that is pathognomic of headache. Variables to be considered in the application of rTMS are frequency of the pulse, coil geometry and position, rise time, depth penetration and safe stimulator design. It affects the levels of neurotransmitters, regulate synaptic plasticity and changes the neuronal networks that are implicated in the pain pathway.This study is designed to assess the efficacy of rTMS in the management of chronic migraine.

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
15.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with migraine without aura with duration of symptoms for more than 15 days in a month for 3 months; non-responsive to medical treatment and willing to give consent will be included in the study.

排除标准

  • Patients with headache secondary to Chronic tension-type and medication overuse Patients with abnormal computed tomography (CT) or magnetic resonance imaging (MRI) of the brain or with abnormal conventional EEG Patients with depression as determined by Hamilton Depression scale Patients with secondary causes of Headache Pregnant females Patients with epilepsy or family history of epilepsy Patients with a pacemaker, intracranial metal objects, and artificial metal tooth will be excluded also from the study.

结局指标

主要结局

To look for severity of headache reduction between both the groups

时间窗: 1 and 3 months

次要结局

  • To look for improvement in quality of life after treatment between both the groups(3 and 6 months)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Pranjali Batra

Banaras Hindu University

研究点 (1)

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