Migraine DisordersNCT02564822
Effects of the Visual Stimulation on the Motor and Visual Cortex in Migraneurs With and Without Aura
An observational study of Migraine Disorders, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Visual Stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Ages: 18-55 years
- Gender: Both
- Prior headache report
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratório de Neurociência Aplicada (LANA)
Recife, Pernambuco, 50670-901
About this study
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.
Read the 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).
- Conditions
- Migraine Disorders
- Being tested
- Visual Stimulation
- Keywords
- migraine disorders, cortical excitability, transcranial magnetic stimulation, electroencephalography
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual StimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Visual Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day (Before and after visual stimulation)
Secondary outcomes (4)
Changes on short interval intracortical inhibition
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.
Measured: one day (Before and after visual stimulation)
Changes on intracortical facilitation
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.
Measured: one day (Before and after visual stimulation)
Changes from phosphene threshold
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.
Measured: one day (Before and after visual stimulation)
Habituation of Visual Evoked Potentials evaluated by Electroencephalography
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.
Measured: one day (during visual stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Kátia Monte-Silva, PhD, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564822
- Sponsor's protocol ID
- VisualStimulation_Migraine
- Status last verified
- Aug 2018
- First submitted
- 22 Sep 2015
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Visual Stimulation on the Motor and Visual Cortex in Migraneurs With and Without Aura
- ClinicalTrials.gov ID
- NCT02564822
- Acronym / sponsor ID
- VisualStimulation_Migraine
- Conditions
- Migraine Disorders
- Keywords
- migraine disorders, cortical excitability, transcranial magnetic stimulation, electroencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraneurs - Visual stimulation | – | Procedure: Visual StimulationPatients 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. |
| Control - Visual stimulation | – | Procedure: Visual StimulationHealthy 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Ages: 18-55 years
- Gender: Both
- Prior headache report
Key exclusion criteria (7 listed)
- Pregnant women;
- Pacemaker;
- History of seizures;
- Metallic implants in the head;
- Patients with clinical evidence of brain injuries;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Stimulationvolunteers 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. | Procedure or surgery | Control - Visual stimulation, Migraneurs - Visual stimulation |
Primary outcome
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.
4 secondary outcomes
Changes on short interval intracortical inhibition
Time frame: one day (Before and after visual stimulation)
Changes on intracortical facilitation
Time frame: one day (Before and after visual stimulation)
Changes from phosphene threshold
Time frame: one day (Before and after visual stimulation)
Habituation of Visual Evoked Potentials evaluated by Electroencephalography
Time frame: one day (during visual stimulation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kátia Monte-Silva, PhD principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on motor evoked potentials (time frame: one day (Before and after visual stimulation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.