Clinical trial NCT02564822: Effects of the Visual Stimulation on the Motor and Visual Cortex in Migraneurs With and Without Aura
Official title: Effects of the Visual Stimulation on the Motor and Visual Cortex in Migraneurs With and Without Aura
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Keywords: migraine disorders
cortical excitability
transcranial magnetic stimulation
electroencephalography
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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).

Eligibility 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

Primary outcomes:
measure: Changes on motor evoked potentials
timeFrame: one day (Before and after visual stimulation)
Secondary outcomes:
measure: Changes on short interval intracortical inhibition
timeFrame: one day (Before and after visual stimulation)
measure: Changes on intracortical facilitation
timeFrame: one day (Before and after visual stimulation)
measure: Changes from phosphene threshold
timeFrame: one day (Before and after visual stimulation)
measure: Habituation of Visual Evoked Potentials evaluated by Electroencephalography
timeFrame: one day (during visual stimulation)
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Laboratório de Neurociência Aplicada (LANA)
state: PE
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Kátia Monte-Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: