Deep Transcranial Magnetic Stimulation (dTMS) for Prophylaxis of Chronic Migraine: A Proof of Concept Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of episodes per month, reduction in intensity (VAS) of each acute episode, reduction in duration of each acute episode, and reduction in the use of abortive medicines.
研究概览
简要总结
ABSTRACT:
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Introduction: Deep Transcranial Magnetic Stimulation (dTMS) can be an alternative prophylactic treatment for chronic migraine. In the current study, we aim to systematically evaluate the efficacy and safety of dTMS for prophylaxis of Chronic Migraine.
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Methodology: We will conduct a randomized, double-blinded, parallel, sham-controlled trial. Patients with chronic migraine as per ICHD-3, will be enrolled in the study. After enrollment, the patients will then be randomized into two groups: dTMS and sham-control. The demographics and clinical history will be recorded. The patient will then be given the Basic Diagnostic Headache Diary (BDHD) to record the number of episodes, duration, site, character, and triggers of each episode, aura, nausea, vomiting, and abortive medications for a month. The assessment of the precise severity of each episode will be done using a 0-100 Visual Analog Scale (VAS). Before initiation of treatment, the impact of the disease on the patient’s quality of life will also be assessed using the Headache Impact Test-6 (HIT-6) and the Migraine Disability Assessment Scale (MIDAS). The dTMS group will receive 12 sessions of dTMS with a Brainsway™ H7 coil, while the sham-controlled group will undergo a dummy paradigm resembling the treatment protocol using the H7 coil. At the end of the treatment, BDHD, VAS, HIT-6, and MIDAS will be recorded again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria.
- •The patient must have chronic migraine as per ICHD-3: A. Headache migraine-like or tension-type-like on more than or equal to 15 days a month for more than 3 months, and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria for Migraine without aura that is a. Headache attacks lasting 4-72 hr untreated or unsuccessfully treated AND b. Headache has at least two of unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity AND c. During headache at least one of nausea AND or OR vomiting or photophobia and phonophobia AND or OR criteria for Migraine with aura that is one or more of visual, sensory, speech AND or OR language, motor, brainstem or retinal symptoms AND at least three of one aura symptom spreads gradually over more than or equal to 5 minutes, two or more aura symptoms occur in succession, each individual aura symptom lasts 5-60 minutes, at least one aura symptom is unilateral, at least one aura symptom is positive, the aura is accompanied, or followed within 60 minutes, by headache. C. On more than or equal to 8 days a month for more than 3 months, fulfilling any of the following: a. Criteria for Migraine without aura: that is Headache has at least two of unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity AND during headache at least one of nausea and/or vomiting or photophobia and phonophobia b. Criteria for Migraine with aura: One or more of visual, sensory, speech AND or OR language, motor, brainstem or retinal symptoms AND at least three of one aura symptom spreads gradually over more than or equal to 5 minutes, two or more aura symptoms occur in succession, each individual aura symptom lasts 5-60 minutes, at least one aura symptom is unilateral, at least one aura symptom is positive, the aura is accompanied, or followed within 60 minutes, by headache. c. believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D. Not better accounted for by another ICHD-3 diagnosis.
- •The patient must have an unsatisfactory response to at least two prophylactic medications.
- •The patient must be fit for dTMS as per BRAINSway guidelines.
- •The patient must have the ability to understand the language of our assessment tools, here, English.
排除标准
- •Exclusion Criteria.
- •The patient must not have shortness of breath while sitting.
- •The patient must not have a history of seizures, or a family history of genetic epilepsy, any other chronic pain disorder, severe depression (more than 19 on PHQ-9), or substance abuse.
- •Female patients must not be pregnant or breastfeeding.
- •The patient must not have a pacemaker or other metallic implant that is unsafe for TMS.
- •The patient will be excluded if the investigator determines that the patient is at risk because of participation in the trial or has a physical condition that may influence the results of the trial.
结局指标
主要结局
Number of episodes per month, reduction in intensity (VAS) of each acute episode, reduction in duration of each acute episode, and reduction in the use of abortive medicines.
时间窗: Before treatment, Just after treatment, 1 month after treatment
次要结局
- To identify weather variations in chronic migraine: aura or no aura, severity headache, only nause v/s nausea and vomiting affect responses to dTMS.(Before treatment, Just after treatment, 1 month after treatment)
- To assess improvement in daily life of patients with chronic migraine in response to treatment with dTMS.(Before treatment, Just after treatment, 1 month after treatment)
- To assess the safety of dTMS for migraine prophylaxis.(Before treatment, Just after treatment, 1 month after treatment)
研究者
Prof Dr Paresh K Doshi
Jaslok Hospital and Research Center, Mumbai