NCT02564822

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

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

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

September 22, 2015

Last Update Submit

August 22, 2018

Conditions

Keywords

migraine disorderscortical excitabilitytranscranial magnetic stimulationelectroencephalography

Outcome Measures

Primary Outcomes (1)

  • Changes on motor evoked potentials

    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.

    one day (Before and after visual stimulation)

Secondary Outcomes (4)

  • Changes on short interval intracortical inhibition

    one day (Before and after visual stimulation)

  • Changes on intracortical facilitation

    one day (Before and after visual stimulation)

  • Changes from phosphene threshold

    one day (Before and after visual stimulation)

  • Habituation of Visual Evoked Potentials evaluated by Electroencephalography

    one day (during visual stimulation)

Study Arms (2)

Migraneurs - Visual stimulation

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

Control - Visual stimulation

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

Interventions

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 - Visual stimulationMigraneurs - Visual stimulation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório de Neurociência Aplicada (LANA)

Recife, Pernambuco, 50670-901, Brazil

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Photic Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Kátia Monte-Silva, PhD

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2015

First Posted

October 1, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations