Magnetic Therapy in Migraine Prophylaxis

This study has been completed.
Sponsor:
Information provided by:
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
ClinicalTrials.gov Identifier:
NCT00901862
First received: May 12, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Migraine
Device: Pulsed magnetic fields (Quantum MH-2MR bracelet)
Device: Sham pulsed magnetic fields (Quantum MH-2MR bracelet)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Magnetic Therapy in Migraine Prophylaxis; Placebo-Controlled, Double-Blind, Crossed Study

Resource links provided by NLM:


Further study details as provided by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Additional 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
Study First Received: May 12, 2009
Last Updated: May 12, 2009
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

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

ClinicalTrials.gov processed this record on August 18, 2014