NCT00901862

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2007

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
Last Updated

May 14, 2009

Status Verified

May 1, 2009

Enrollment Period

1 year

First QC Date

May 12, 2009

Last Update Submit

May 12, 2009

Conditions

Migraine

Keywords

Migrainetherapymagnetic therapyprophylaxisprevention

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure was change from baseline in the number and peak severity of migraine attacks during each double-blind phase

    3 months

Secondary Outcomes (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

    6 months

Study Arms (2)

1 Active PEFs

ACTIVE COMPARATOR

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)

2 Sham

SHAM COMPARATOR

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)

Interventions

Pulsed magnetic fields (Quantum MH-2MR bracelet)DEVICE

Pulsed magnetic fields

1 Active PEFs
Sham pulsed magnetic fields (Quantum MH-2MR bracelet)DEVICE

Hybrid circuits crucial for the generation of the electromagnetic field had been removed.

2 Sham

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Neurologia y Neurocirugía Manuel Velasco Suarez

Mexico City, Mexico City, 14269, Mexico

Location

Related Publications (1)

  • San-Juan D, Pon AA, Pohls FZ, Del Castillo-Calcaneo Jde D, Perez-Neri I, Rios C. Peripheral pulsed electromagnetic fields may reduce the placebo effect in migraine patients that do not respond to the sham intervention in a randomized, placebo-controlled, double-blind, cross-over clinical trial. Complement Ther Med. 2012 Feb-Apr;20(1-2):31-7. doi: 10.1016/j.ctim.2011.09.006. Epub 2011 Oct 15.

    PMID: 22305246DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • DANIEL SAN JUAN ORTA, MD

    Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 14, 2009

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

May 14, 2009

Record last verified: 2009-05

Locations

ME(1)