University Putra Malaysia
Serdang, Selangor, 43400, Malaysia
NCT Number: NCT03556722
This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Serdang, Selangor, 43400, Malaysia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High frequency rTMS on left dorsolateral prefrontal cortex.
Other names: rTMS
Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.
Other names: Placebo
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During treatment and up until 1 month post treatment
Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki.
Time frame: Baseline and at month 3 post treatment
Mean score changes from baseline for depression, anxiety and stress category.
Time frame: Baseline and at month 3 post treatment
Mean score changes from baseline.
Time frame: Baseline and at month 3 post treatment
Mean score changes from baseline.
Time frame: Baseline and at month 3 post treatment
Mean score changes from baseline.
Time frame: Baseline and at month 3 post treatment
Mean score changes from baseline for sleep quality.
Time frame: Baseline
Measuring food frequency intake at baseline
Time frame: Baseline and at month 3 post treatment
Mean score changes from baseline.
Time frame: Baseline and at month 3 post treatment
Mean flow velocity (cm/s).
Time frame: Baseline and at month 3 post treatment
EEG pattern differences based on report.
Time frame: Baseline and at month 3 post treatment
Serum serotonin (ng/ml).
Time frame: Baseline and at month 3 post treatment
Serum beta endorphin (ng/ml).
Time frame: Baseline and at month 3 post treatment
Serum CGRP (pg/ml).
Time frame: At month 3 post treatment
A 5-point, Likert scale will be used to evaluate satisfaction with rTMS in migraine prevention.
Universiti Putra Malaysia
Other
Effectiveness and Tolerability of Repetitive Transcranial Magnetic Stimulation For Preventive Treatment Of Episodic Migraine: A Single Centre, Randomised, Double-Blind, Sham-Controlled Phase 2 Trial
Acronym: Magnet-EM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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