Pulsed Electromagnetic Field Therapy in the Refractory Migraine

Refractory Migraine Clinical Trial

Official title:

A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670214
• Other study ID #: NIYAYESH CLINIC 1
• Status: Completed
• Phase: N/A
• First received: January 24, 2012
• Last updated: February 15, 2016
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: August 2012
• Source: Niyayesh Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of migraine or decrease them even in the patients with refractory migraine.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 55 Years

Eligibility

Inclusion Criteria:

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.

1. Failed adequate trails of preventive medicines, alone or in combination from at least 2 of 4 drug classes:

• Beta-blockers

• Anticonvulsants

• Tricyclics

• Calcium channel blockers

2. Failed adequate trials of abortive medicines from the following classes, unless contraindicated:

• Both a triptan and DHE intranasal or injectable formulation

• Either nonsteroidal anti-inflammatory drugs or combination analgesics

• Adequate trial Period of time during which an appropriate dose of medicine is administered, typically at least 2 months at optimal or maximum-tolerated doses, unless terminated early due to adverse effects

• Modifiers With or without medication overuse, as defined by ICHD-2

• With significant disability, as defined by MIDAS > 11

• [DHE = dihydroergotamine; ICHD = International Classification of Headache Disorders;MIDAS = Migraine Disability Assessment]

• The prophylactic medications have been discontinued at least one month prior to enrollment

Exclusion Criteria:

• pregnancy

• epilepsy

• malignancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Refractory Migraine

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Niyayesh clinic	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Niyayesh Clinic	Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

B Hatef, B Majdoleslam, M Toghae, F Hashemirad. The Prophylactic Treatment of PEMF in the Refractory Migraine Headache, Double-Blind, Parallel Placebo-Controlled Study. CEPHALALGIA 33(s8): 98-99, 2013

Boshra Hatef, Fahime Hashemirad, Gholam Hossein Meftahi, Leila Simorgh, Soodeh Razeghi Jahromi, Forough Rahimi, Mansoureh ToghaThe efficiency of pulsed electromagnetic field in refractory migraine headaches: a randomized, single-blinded, placebo-controlle

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MIDAS	migraine disability score	6 months	Yes
Primary	headache frequency		4 months	Yes
Primary	headache duration		4 months	Yes
Primary	headache intensity		4 months	Yes
Secondary	medications		4 months	Yes
Secondary	missed work		4 months	Yes

External Links

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