Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)
- Conditions
- Migraine
- Interventions
- Device: Repetitive Transcranial Magnetic Stimulation.Device: Sham rTMS
- Registration Number
- NCT03556722
- Lead Sponsor
- Universiti Putra Malaysia
- Brief Summary
This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.
- Detailed Description
Migraine patients according to International Headache Society criteria will be allocated randomly into two treatment arms. One group will receive active rTMS and another group will receive sham rTMS for treatment phase (5 sessions). Assessment will be made at baseline, month 1, month 2 and month 3 post-treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description repetitive Transcranial Magnetic Stimulation Repetitive Transcranial Magnetic Stimulation. Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Coil given on left dorsolateral prefrontal cortex for five sessions. Sham repetitive Transcranial Magnetic Stimulation Sham rTMS Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Sham Coil given on left dorsolateral prefrontal cortex for five sessions.
- Primary Outcome Measures
Name Time Method Change from baseline in mean monthly migraine days. Baseline and month 1, 2 and 3 post treatment The mean monthly migraine days will be calculated using the monthly migraine days from each of the month of the double-blind treatment phase.
- Secondary Outcome Measures
Name Time Method Electroencephalography (EEG) pattern change in migraine patients in response to rTMS. Baseline and at month 3 post treatment EEG pattern differences based on report.
Serum serotonin level in migraine patients in response to rTMS. Baseline and at month 3 post treatment Serum serotonin (ng/ml).
Serum Calcitonin gene related peptide (CGRP) level in migraine patients in response to rTMS. Baseline and at month 3 post treatment Serum CGRP (pg/ml).
The Pittsburgh Sleep Quality Index score changes in migraine in response to rTMS. Baseline and at month 3 post treatment Mean score changes from baseline for sleep quality.
Satisfaction measures of efficacy, tolerability, safety and expectations of rTMS among the participants. At month 3 post treatment A 5-point, Likert scale will be used to evaluate satisfaction with rTMS in migraine prevention.
The Migraine Specific Questionnaire (MSQ) version 2.1 score changes in migraine patients in response to r-TMS. Baseline and at month 3 post treatment Mean score changes from baseline.
The EQ-5D score changes in migraine patients in response to rTMS. Baseline and at month 3 post treatment Mean score changes from baseline.
The Depression Anxiety Stress Scale (DASS 21) score changes in migraine patients in response to rTMS. Baseline and at month 3 post treatment Mean score changes from baseline for depression, anxiety and stress category.
Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS. Baseline and at month 3 post treatment Mean flow velocity (cm/s).
Change from baseline in mean monthly migraine attacks. Baseline and month 1, 2 and 3 post treatment The mean monthly migraine attacks will be calculated using the monthly migraine attack from each of the month of the double-blind treatment phase.
Proportion of subjects with at least a 50% reduction from baseline in mean monthly migraine days. Baseline and month 1, 2 and 3 post treatment Change from baseline in mean monthly pain intensity of migraine attacks. The mean monthly pain intensity will be based on the record of the maximal pain intensity by means of a verbal scale (i.e. 0 =no headache; 1 = mild headache; 2 = moderate headache; 3 = severe headache) prior to taking symptomatic medication.
Frequency and severity of adverse events in response to rTMS. During treatment and up until 1 month post treatment Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki.
The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS. Baseline and at month 3 post treatment Mean score changes from baseline.
The Food Frequency Questionnaire score in migraine patients Baseline Measuring food frequency intake at baseline
The Global Physical Activity Questionnaire score change in migraine in response to rTMS. Baseline and at month 3 post treatment Mean score changes from baseline.
Serum beta-endorphin level changes in migraine patients in response to rTMS. Baseline and at month 3 post treatment Serum beta endorphin (ng/ml).
Trial Locations
- Locations (1)
University Putra Malaysia
🇲🇾Serdang, Selangor, Malaysia