An interventional study of pulsed electromagnetic field in Refractory Migraine, sponsored by Niyayesh Clinic. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 17 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-02-17.
Sponsored by Niyayesh Clinic · Not applicable, Interventional, and Treatment
Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of migraine or decrease them even in the patients with refractory migraine.
Migraine is most common among patients who seek medical care for headache. The prevalence of migraine is around 10 % in Iran. The many studies of migraine pathophysiology imply that the brain of migraine patient is impaired in term of cerebral circulation and baseline activity of brain stem, monoaminergic system and cortex. Then headache is only a sign of the changes that occur in the brain to rid hazardous conditions. Based on this theory many electrophysiological and imaging abnormalities that were appeared in the brain before the aura or the headache were diminished in the early phases of the attack. It means the changes concurrent with headache are associated with a quasi normalization of cortical information processing. The different pharmacological and non-pharmacological treatments have proposed for migraine management. But some patients do not satisfactorily respond to or cannot tolerate current evidence-based treatments. This group of patients is often said to have refractory migraine (RM). Thus according to the enigmatic pathophysiology of migraine, a comprehensive treatment that affected all contributing factors in the migraine with minimal side effects is not provided yet.
Extremely low frequency magnetic fields (ELF MFs) as non-pharmacological treatment of migraine had good effect with weak evidence in the control of migraine. Recently based on extensive studies in the bioeffects of the low frequency electromagnetic field we can hope that this method can respond to many human disorders is unsolvable. The purpose of this study is to apply the best effective treatment protocol of ELF-MF on brain and circulatory system is extracted by using the latest findings of studies of low-frequency electromagnetic fields as intervention and apply it for refractory migraine patients in the form of a randomized one-blind placebo- controlled trial study. The evaluation of interventions is done subjectively (migraine dairy and MIDAS). Also we consider follow up period to confirm results.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →This is the only study on the registry with Niyayesh Clinic as lead sponsor.
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Primary Diagnosis A. ICHD-II migraine or chronic migraine Refractory B. Headaches cause significant interference with function or quality of life despite modification of triggers, lifestyle factors, and adequate trials of acute and preventive medicines with established efficacy.
Failed adequate trails of preventive medicines, alone or in combination from at least 2 of 4 drug classes:
Failed adequate trials of abortive medicines from the following classes, unless contraindicated:
Exclusion Criteria:
parameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions phase 1 treatment and added 6 sessions for phase 2 treatment (3 sessions per week)
Procedure: pulsed electromagnetic field
patients are placed under off instrument while who is kept blind to know it for 6 sessions (3 sessions per week).
Procedure: pulsed electromagnetic field
parameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions( 2 week) for placebo and phase 1 treatment ( 3 sessions in week) and added 6 sessions for phase 2 treatment. the solenoid diameter of instrument is 70 cm is placed around the head.
MIDAS
migraine disability score
Time frame: 6 months
headache frequency
Time frame: 4 months
headache duration
Time frame: 4 months
headache intensity
Time frame: 4 months
medications
Time frame: 4 months
missed work
Time frame: 4 months
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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