<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01670214</url>
  </required_header>
  <id_info>
    <org_study_id>NIYAYESH CLINIC 1</org_study_id>
    <nct_id>NCT01670214</nct_id>
  </id_info>
  <brief_title>Pulsed Electromagnetic Field Therapy in the Refractory Migraine</brief_title>
  <official_title>A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Niyayesh Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Niyayesh Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of&#xD;
      migraine or decrease them even in the patients with refractory migraine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Migraine is most common among patients who seek medical care for headache. The prevalence of&#xD;
      migraine is around 10 % in Iran. The many studies of migraine pathophysiology imply that the&#xD;
      brain of migraine patient is impaired in term of cerebral circulation and baseline activity&#xD;
      of brain stem, monoaminergic system and cortex. Then headache is only a sign of the changes&#xD;
      that occur in the brain to rid hazardous conditions. Based on this theory many&#xD;
      electrophysiological and imaging abnormalities that were appeared in the brain before the&#xD;
      aura or the headache were diminished in the early phases of the attack. It means the changes&#xD;
      concurrent with headache are associated with a quasi normalization of cortical information&#xD;
      processing. The different pharmacological and non-pharmacological treatments have proposed&#xD;
      for migraine management. But some patients do not satisfactorily respond to or cannot&#xD;
      tolerate current evidence-based treatments. This group of patients is often said to have&#xD;
      refractory migraine (RM). Thus according to the enigmatic pathophysiology of migraine, a&#xD;
      comprehensive treatment that affected all contributing factors in the migraine with minimal&#xD;
      side effects is not provided yet.&#xD;
&#xD;
      Extremely low frequency magnetic fields (ELF MFs) as non-pharmacological treatment of&#xD;
      migraine had good effect with weak evidence in the control of migraine. Recently based on&#xD;
      extensive studies in the bioeffects of the low frequency electromagnetic field we can hope&#xD;
      that this method can respond to many human disorders is unsolvable. The purpose of this study&#xD;
      is to apply the best effective treatment protocol of ELF-MF on brain and circulatory system&#xD;
      is extracted by using the latest findings of studies of low-frequency electromagnetic fields&#xD;
      as intervention and apply it for refractory migraine patients in the form of a randomized&#xD;
      one-blind placebo- controlled trial study. The evaluation of interventions is done&#xD;
      subjectively (migraine dairy and MIDAS). Also we consider follow up period to confirm&#xD;
      results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MIDAS</measure>
    <time_frame>6 months</time_frame>
    <description>migraine disability score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>headache frequency</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>headache duration</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>headache intensity</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>medications</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>missed work</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Refractory Migraine</condition>
  <arm_group>
    <arm_group_label>Pulsed electromagnetic field</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pulsed electromagnetic field</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients are placed under off instrument while who is kept blind to know it for 6 sessions (3 sessions per week).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pulsed electromagnetic field</intervention_name>
    <description>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.</description>
    <arm_group_label>Pulsed electromagnetic field</arm_group_label>
    <arm_group_label>pulsed electromagnetic field</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Primary Diagnosis A. ICHD-II migraine or chronic migraine Refractory B. Headaches cause&#xD;
        significant interference with function or quality of life despite modification of triggers,&#xD;
        lifestyle factors, and adequate trials of acute and preventive medicines with established&#xD;
        efficacy.&#xD;
&#xD;
          1. Failed adequate trails of preventive medicines, alone or in combination from at least&#xD;
             2 of 4 drug classes:&#xD;
&#xD;
               -  Beta-blockers&#xD;
&#xD;
               -  Anticonvulsants&#xD;
&#xD;
               -  Tricyclics&#xD;
&#xD;
               -  Calcium channel blockers&#xD;
&#xD;
          2. Failed adequate trials of abortive medicines from the following classes, unless&#xD;
             contraindicated:&#xD;
&#xD;
               -  Both a triptan and DHE intranasal or injectable formulation&#xD;
&#xD;
               -  Either nonsteroidal anti-inflammatory drugs or combination analgesics&#xD;
&#xD;
               -  Adequate trial Period of time during which an appropriate dose of medicine is&#xD;
                  administered, typically at least 2 months at optimal or maximum-tolerated doses,&#xD;
                  unless terminated early due to adverse effects&#xD;
&#xD;
               -  Modifiers With or without medication overuse, as defined by ICHD-2&#xD;
&#xD;
               -  With significant disability, as defined by MIDAS &gt; 11&#xD;
&#xD;
               -  [DHE = dihydroergotamine; ICHD = International Classification of Headache&#xD;
                  Disorders;MIDAS = Migraine Disability Assessment]&#xD;
&#xD;
               -  The prophylactic medications have been discontinued at least one month prior to&#xD;
                  enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boshra Hatef, Phd student PT,TMU</last_name>
    <role>Principal Investigator</role>
    <affiliation>Niyayesh Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>mansoore toghae, prof. neurology,TUMS</last_name>
    <role>Study Director</role>
    <affiliation>sina hospital of Medical Science University of Tehran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Niyayesh clinic</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <link>
    <url>http://www.ijclinicaltrials.com/index.php/ijct/article/view/99</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>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</citation>
  </reference>
  <results_reference>
    <citation>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-controlled, parallel group. international journal of clinical trial 3(1): 24-31, 2016</citation>
  </results_reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>January 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>February 15, 2016</last_update_submitted>
  <last_update_submitted_qc>February 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tarbiat Modarres University</investigator_affiliation>
    <investigator_full_name>Boshra Hatef</investigator_full_name>
    <investigator_title>Phd student of physiotherapy</investigator_title>
  </responsible_party>
  <keyword>RM</keyword>
  <keyword>R-CM</keyword>
  <keyword>based on ICHD-2 criteria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01670214
org study id: NIYAYESH CLINIC 1
nct id: NCT01670214
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: MIDAS
time frame: 6 months
description: migraine disability score
measure: headache frequency
time frame: 4 months
measure: headache duration
time frame: 4 months
measure: headache intensity
time frame: 4 months
measure: medications
time frame: 4 months
measure: missed work
time frame: 4 months
arm group label: Pulsed electromagnetic field
arm group type: Active Comparator
description: 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)
arm group label: pulsed electromagnetic field
arm group type: Placebo Comparator
description: patients are placed under off instrument while who is kept blind to know it for 6 sessions (3 sessions per week).
intervention type: Procedure
intervention name: pulsed electromagnetic field
description: 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.
arm group label: Pulsed electromagnetic field
arm group label: pulsed electromagnetic field
criteria: 
gender: All
minimum age: 17 Years
maximum age: 55 Years
healthy volunteers: No
last name: Boshra Hatef, Phd student PT,TMU
role: Principal Investigator
affiliation: Niyayesh Clinic
last name: mansoore toghae, prof. neurology,TUMS
role: Study Director
affiliation: sina hospital of Medical Science University of Tehran
facility: 
country: Iran, Islamic Republic of
url: http://www.ijclinicaltrials.com/index.php/ijct/article/view/99
description: Related Info
citation: 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
citation: 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-controlled, parallel group. international journal of clinical trial 3(1): 24-31, 2016
responsible party type: Principal Investigator
investigator affiliation: Tarbiat Modarres University
investigator full name: Boshra Hatef
investigator title: Phd student of physiotherapy
mesh term: Migraine Disorders