Health Condition 1: G437- Chronic migraine without aura
Conditions
Sponsors
Jaslok Hospital and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria - 1. 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. 2. The patient must have an unsatisfactory response to at least two prophylactic medications. 3. The patient must be fit for dTMS as per BRAINSway guidelines. 4. The patient must have the ability to understand the language of our assessment tools, here, English.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Before treatment, Just after treatment, 1 month after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify weather variations in chronic migraine: aura or no aura, severity headache, only nause v/s nausea and vomiting affect responses to dTMS.Timepoint: 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.Timepoint: Before treatment, Just after treatment, 1 month after treatment;To assess the safety of dTMS for migraine prophylaxis.Timepoint: Before treatment, Just after treatment, 1 month after treatment | — |
Countries
India
Contacts
Public ContactProf Dr Paresh K Doshi
Jaslok Hospital and Research Center, Mumbai
Outcome results
None listed