Text Size

Pulsed Electromagnetic Field Therapy in the Refractory Migraine

This study is currently recruiting participants.
Verified August 2012 by Niyayesh Clinic
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Boshra Hatef, Tarbiat Modarres University
ClinicalTrials.gov Identifier:
NCT01670214
First received: January 24, 2012
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
Refractory Migraine
 Procedure: pulsed electromagnetic field

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Niyayesh Clinic:

Primary Outcome Measures:
  • MIDAS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    migraine disability score

  • headache frequency [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • headache duration [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • headache intensity [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • medications [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • missed work [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pulsed electromagnetic field
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
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.
Placebo Comparator: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   17 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670214

Contacts
Contact: Boshra Hatef, Phd student PT,TMU 00982122088285 boshrahatef@yahoo.com

Locations
Iran, Islamic Republic of
Niyayesh clinic Recruiting
Tehran, Iran, Islamic Republic of
Contact: Boshra Hatef, Phd student PT,TMU     00982122088285     boshrahatef@yahoo.com    
Principal Investigator: Boshra Hatef, Phd student PT,TMU            
Sub-Investigator: Fahime Hashemirad, Msc PT,TUMS            
Sponsors and Collaborators
Niyayesh Clinic
Tehran University of Medical Sciences
Investigators
Principal Investigator: Boshra Hatef, Phd student PT,TMU Niyayesh Clinic
Study Director: mansoore toghae, prof. neurology,TUMS sina hospital of Medical Science University of Tehran
  More Information

No publications provided

Responsible Party: Boshra Hatef, Phd student of physiotherapy, Tarbiat Modarres University
ClinicalTrials.gov Identifier: NCT01670214     History of Changes
Other Study ID Numbers: NIYAYESH CLINIC 1
Study First Received: January 24, 2012
Last Updated: August 21, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Niyayesh Clinic:
RM
R-CM
based on ICHD-2 criteria

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013