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Magnetic Therapy in Migraine Prophylaxis

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ClinicalTrials.gov Identifier: NCT00901862
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : May 14, 2009
Sponsor:
Information provided by:
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Brief Summary:

Background: The therapy with pulsed electromagnetic fields (PEFs) has been used as a therapeutic modality for at least 40 years. However, their effect in the migraine prophylaxis is unclear.

Objectives: Evaluate the prophylactic effectiveness of the therapy with PEFs in the handling of migraines.

Methodology: Placebo-controlled, randomized, double-blind, crossed clinical study.


Condition or disease Intervention/treatment Phase
Migraine Device: Pulsed magnetic fields (Quantum MH-2MR bracelet) Device: Sham pulsed magnetic fields (Quantum MH-2MR bracelet) Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Magnetic Therapy in Migraine Prophylaxis; Placebo-Controlled, Double-Blind, Crossed Study
Study Start Date : March 2007
Primary Completion Date : March 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Active PEFs
The pulsed electromagnetic fields were directed to the wrist. The model used has the form of a bracelet called Quantum MH-2MR which uses, as a source of power, an alkaline battery of 1.5 volts connected to an electronic circuit formed by two hybrid circuits of magnetic oscillation and a control system of all the generating frequency system.
Device: Pulsed magnetic fields (Quantum MH-2MR bracelet)
Pulsed magnetic fields
Sham Comparator: 2 Sham
The sham machines were identical to the machines in actual operation in both phases of the study. The only difference was that the hybrid circuits crucial for the generation of the electromagnetic field had been removed.
Device: Sham pulsed magnetic fields (Quantum MH-2MR bracelet)
Hybrid circuits crucial for the generation of the electromagnetic field had been removed.



Primary Outcome Measures :
  1. The primary outcome measure was change from baseline in the number and peak severity of migraine attacks during each double-blind phase [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. The secondary outcome was the proportion of patients who responded to each treatment with at least a 50% reduction in migraine attacks relative to baseline [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 18-55 years
  • Fulfilled the diagnose criteria of migraine with and without aura in agreement to the International Headache Classification, 2004

Exclusion Criteria:

  • Patients with cluster, medicines overuse, post-traumatic headache, sinusitis or other headache types
  • Women who were pregnant, became pregnant during the study or were lactating
  • Patients who were under other prophylactic treatments of migraine or did not signed the informed consent were excluded from this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901862


Locations
Mexico
Instituto Nacional de Neurologia y Neurocirugía Manuel Velasco Suarez
Mexico City, Mexico, 14269
Sponsors and Collaborators
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Investigators
Principal Investigator: DANIEL SAN JUAN ORTA, MD Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DANIEL SAN JUAN ORTA, Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
ClinicalTrials.gov Identifier: NCT00901862     History of Changes
Other Study ID Numbers: 105/06
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 2009

Keywords provided by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez:
Migraine
therapy
magnetic therapy
prophylaxis
prevention

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