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Effects of the Visual Stimulation on the Motor and Visual Cortex in Migraneurs With and Without Aura

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ClinicalTrials.gov Identifier: NCT02564822
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to investigate the motor and visual cortex excitability in response to visual stimulation of migraineurs with and without aura compared to healthy individuals. For this purpose, electrical cortical activity of migraineurs will be compared to healthy volunteers.

Condition or disease Intervention/treatment
Migraine Disorders Procedure: Visual Stimulation

Detailed Description:
A cross sectional study to compare the best approach to migraineurs evaluation. For this, healthy individuals, after reading and signing the free and informed consent will be submitted to a single session to obtain the normal neurophysiological endpoints and thus compare with those obtained in individuals with migraineurs volunteers. All volunteers (healthy and migraineurs) will be submitted to a neurophysiological evaluation through transcranial magnetic stimulation (TMS) and electroencephalography (EEG). A visual stimulation will be delivered during the assessment of habituation through visual evoked potential volunteers (VEP-habituation) and the following measures will be evaluated before and after visual stimulation: (i) Motor Evoked Potentials (MEP); (ii) Motor Threshold (MT); (iii) Short Interval Cortical Inhibition (SICI); (iv) Intracortical Facilitation (lCF) and (v) Phosphene Threshold (PT).

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Time Perspective: Cross-Sectional
Official Title: Effects of the Visual Stimulation on the Motor and Visual Cortex in Migraneurs With and Without Aura
Study Start Date : July 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Migraneurs
Patients will be recruited via advertisements on the university. Patients should have migraine diagnosis according to the International Classification of Headache Disorders (ICHD-III) criteria and clinical diagnosis by a neurologist.
Procedure: Visual Stimulation
volunteers will be invited to sit in a comfortable chair, in a calm and dark room, at 90 cm of distance from computer screen. It will be asked to fix his right eye visual field on a red point at the center of the screen (the left one will be blindfolded). Visual stimuli will be a black and White grid pattern, alternating at a frequency of 3.1 Hz.
Control
Healthy volunteers will be recruited via advertisements on the university. For control subjects the individuals should not have migraine diagnosis assessed according to IHCD-III criteria.
Procedure: Visual Stimulation
volunteers will be invited to sit in a comfortable chair, in a calm and dark room, at 90 cm of distance from computer screen. It will be asked to fix his right eye visual field on a red point at the center of the screen (the left one will be blindfolded). Visual stimuli will be a black and White grid pattern, alternating at a frequency of 3.1 Hz.


Outcome Measures

Primary Outcome Measures :
  1. Changes on motor evoked potentials [ Time Frame: one day (Before and after visual stimulation) ]
    to measure MEP, the intensity of the magnetic stimulator will be adjusted to 120% of rest motor threshold and 10 stimuli will be registered. For evaluation volunteers will be instructed to sit in a chair and get into a comfortable position. Initially, single-pulse TMS will be administered over the motor cortex to determine the cortical representation area of the first dorsal interosseous muscle (FDI). For all evaluations the same figure-eight coil is used, in order to avoid measurement bias. Amplitude means of evoked potentials will determine the MEP.


Secondary Outcome Measures :
  1. Changes on short interval intracortical inhibition [ Time Frame: one day (Before and after visual stimulation) ]
    to evaluate this variable, subthreshold conditioning stimuli (80% of RMT) and suprathreshold test stimuli (120% of RMT) will be delivered at an inter stimulus intervals (ISI) of 2 milliseconds, to determine the short interval cortical inhibition (SICI). Ten stimuli will be applied in each condition (unconditioned pulse and pairs of stimuli with ISI of 2 milliseconds). The order of stimulus delivered will be pseudorandomized and SICI will be expressed as a percentage of a conditioned stimuli in regarding an unconditioned stimuli.

  2. Changes on intracortical facilitation [ Time Frame: one day (Before and after visual stimulation) ]
    to evaluate intracortical facilitation (ICF), subthreshold conditioning stimuli (80% of RMT) and suprathreshold test stimuli (120% of RMT) will be delivered at an inter stimulus intervals (ISI) of 10 milliseconds. Ten stimulus will be applied in each condition (unconditioned pulse and pairs of stimuli with ISI of 10 milliseconds). The order of stimuli delivered will be pseudorandomized and ICF will be expressed as a percentage of a conditioned stimuli in regarding an unconditioned stimuli.

  3. Changes from phosphene threshold [ Time Frame: one day (Before and after visual stimulation) ]
    a 10-cm circular coil was used that has giving a peak magnetic field strength of 2 tesla. Subjects were asked to wear a blindfold, sit comfortably in a chair and to close their eyes to diminish ambient light.In sagittal line, three points were scored: 2, 3 and 4 cm above the inion. The single pulse TMS was applied to one of the points scored and the subject was asked to report the presence or absence of a phosphene immediately after stimulation. The stimulation was repeated ten times at each intensity with a maximum frequency of 0.2 Hz, stimulation was initially applied to 60% of the maximum intensity of the stimulator. The intensity of stimulation was changed into blocks of 5% to minimum intensity that the subject can perceive the phosphene certainly, five times ten, then this value was set as the PT.

  4. Habituation of Visual Evoked Potentials evaluated by Electroencephalography [ Time Frame: one day (during visual stimulation) ]
    volunteers will be invited to sit in a comfortable chair, in a calm and dark room, at 90 cm of distance from computer screen. It will be asked to fix his right eye visual field on a red point at the center of the screen (the left one will be blindfolded). Visual stimuli will be a black and White grid pattern, alternating at a frequency of 3.1 Hz. Electrodes used to record data will be localized on Oz and Fz points according International 10-20 system. During the test, 600 cortical answers will be recorded. Data will be collected and recorded in a personal computer, and after, converted to the ".txt" format to futures analysis with MATLAB.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients and healthy volunteers will be recruited via advertisements on the university. Patients should have migraine diagnosis according to the International Classification of Headache Disorders (ICHD-III) criteria and clinical diagnosis by a neurologist.

For control subjects the individuals should not have migraine diagnosis assessed according to IHCD-III criteria.

Criteria

Inclusion Criteria:

  • Ages: 18-55 years
  • Gender: Both
  • Prior headache report

Exclusion Criteria:

  • Pregnant women;
  • Pacemaker;
  • History of seizures;
  • Metallic implants in the head;
  • Patients with clinical evidence of brain injuries;
  • Chronic pain associated to others diseases;
  • Use of neuroleptic medications
Contacts and Locations

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): NCT02564822


Contacts
Contact: Kátia Monte-Silva, PhD monte.silvakk@gmail.com
Contact: Lívia Nascimento, Graduated livia.sgn@gmail.com

Locations
Brazil
Laboratório de Neurociência Aplicada (LANA) Recruiting
Recife, PE, Brazil, 50670-901
Contact: Lívia Nascimento, Graduated       livia.sgn@gmail.com   
Contact: Fernanda Nogueira, Graduation       fernandanrn@gmail.com   
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
Principal Investigator: Kátia Monte-Silva, PhD Universidade Federal de Pernambuco
More Information

Responsible Party: Kátia Monte-Silva, Principal Investigator, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02564822     History of Changes
Other Study ID Numbers: VisualStimulation_Migraine
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by Kátia Monte-Silva, Universidade Federal de Pernambuco:
migraine disorders
cortical excitability
transcranial magnetic stimulation
electroencephalography

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