Cognitive Function and Autonomic Regulation in Patients With Migraine
1 other identifier
interventional
100
1 country
1
Brief Summary
Individuals with migraine have impaired cognitive function and worse autonomic function compared to individuals without migraine. Objective: To evaluate the autonomic function and cognition in young individuals with migraine compared to healthy individuals without migraine. Methods: Cross-sectional study will be carried out at University of Fortaleza with individuals with previous migraines diagnoses and healthy volunteers without migraines. Volunteers of both sexes, aged between 18 and 60 years, clinically diagnosed with migraine or not, who have not undergone any type of drug treatment for at least three months and who accept to participate in the research will be enrolled in the research. Individuals who have comorbidities such as hypertension and Diabetes mellitus (type I and II), respiratory, cardiac and/or chronic vascular diseases, have suffered any significant facial trauma, have a cognitive problem or dysfunction associated with cognition, or have suffered any episode of stroke or transient ischemic attack prior to conducting this research will not be enrolled. Participants will be assessed through cognitive tests, and autonomic function such as Neck Disability Index, Migraine Disability Assessment Questionnaire, Stroop Colo test, digit symbol substitution test, Addenbrooke's cognitive examination, mini-mental state examination, Montreal Cognitive Assessment, Trail Making Test A and B and reaction time test and by MindWave Mobile® devices and Polar V800®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
1 active site
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
January 15, 2020
CompletedFirst Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedApril 28, 2021
April 1, 2021
11 months
February 12, 2020
April 27, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Cognition
Cognitive tests composite will be impaired in the Migraine group compared to healthy subjects. Cognition will be tested by Stroop Color test, digit symbol substitution test, addenbrooke's cognitive examination 3, mini-mental state examination, Montreal Cognitive Assessment, Trail Making Test A e B and reaction time test.
one week
Attention and concentration test
Concentration and attention will be recorded during the cognition test
one week
Sympathetic activation
Sympathetic nervous system will be recorded by R-R intervals
one week
Study Arms (2)
Control Group
ACTIVE COMPARATORCognitive tests will be performed to check if cognition is impaired in patients with migraine compared to healthy control. An R-R ECG recording will be recorded to evaluate the heart rate variability and then the sympathetic nervous system activation. Concentration and attention will be recorded with the MindWave headset during all cognitive tests.
Migrain Group
EXPERIMENTALCognitive tests will be performed to check if cognition is impaired in patients with migraine compared to healthy control. An R-R ECG recording will be recorded to evaluate the heart rate variability and then the sympathetic nervous system activation. Concentration and attention will be recorded with the MindWave headset during all cognitive tests.
Interventions
Cognition tests will be performed with questionnaires, which will be applied to the main investigator. Stroop Color test, digit symbol substitution test, Addenbrooke's cognitive examination 3, mini-mental state examination, Montreal Cognitive Assessment, Trail Making Test A e B and Reaction time test will be performed to check the cognition in all volunteers.
The sympathetic activation will be evaluated by heart rate variability. Volunteers will have their hear rate recorded by a frequencymeter and the R-R interval will be analyzed to ch check the central nervous system activation during all cognitive tests.
Concentration and attention measures will be recorded with the MindWave headset during all cognitive tests. The EEG will be recorded with the MindWave and then alfa wave will be analized to check the attention and concentration levels.
Eligibility Criteria
You may qualify if:
- Migraine diagnosis
You may not qualify if:
- Previous stroke
- Type I or II diabetes
- Heart disease
- vascular diseases
- previous cognition impairment
- mental disorders
- color blindness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Fortaleza
Fortaleza, Ceará, 60811-905, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mayron Oliveira, Professor
Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 17, 2020
Study Start
January 15, 2020
Primary Completion
December 15, 2020
Study Completion
December 15, 2020
Last Updated
April 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share