NCT01670214

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 17, 2016

Status Verified

August 1, 2012

Enrollment Period

1.6 years

First QC Date

January 24, 2012

Last Update Submit

February 15, 2016

Conditions

Refractory Migraine

Keywords

RMR-CMbased on ICHD-2 criteria

Outcome Measures

Primary Outcomes (4)

  • MIDAS

    migraine disability score

    6 months

  • headache frequency

    4 months

  • headache duration

    4 months

  • headache intensity

    4 months

Secondary Outcomes (2)

  • medications

    4 months

  • missed work

    4 months

Study Arms (2)

Pulsed electromagnetic field

ACTIVE COMPARATOR

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

pulsed electromagnetic field

PLACEBO COMPARATOR

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

Interventions

pulsed electromagnetic fieldPROCEDURE

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.

Pulsed electromagnetic fieldpulsed electromagnetic field

Eligibility Criteria

Age17 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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:
  • Beta-blockers
  • Anticonvulsants
  • Tricyclics
  • Calcium channel blockers
  • 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

You may not qualify if:

  • pregnancy
  • epilepsy
  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niyayesh clinic

Tehran, Iran

Location

Related 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

    BACKGROUND

  • 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

    RESULT

Related Links

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Boshra Hatef, Phd student PT,TMU

    Niyayesh Clinic

    PRINCIPAL INVESTIGATOR

  • mansoore toghae, prof. neurology,TUMS

    sina hospital of Medical Science University of Tehran

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd student of physiotherapy

Study Record Dates

First Submitted

January 24, 2012

First Posted

August 22, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

February 17, 2016

Record last verified: 2012-08

Locations

IR(1)