Cognitive Function and Autonomic Regulation in Patients With Migraine

NCT04272229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-04-28

No results posted yet for this study

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®.

Conditions

  • Migraine Disorders

Interventions

DIAGNOSTIC_TEST

Cognition

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.

DIAGNOSTIC_TEST

Sympathetic Nervous System

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.

DIAGNOSTIC_TEST

Concentratio and Attention

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.

Sponsors & Collaborators

  • Fortaleza University

    lead OTHER

Principal Investigators

  • Mayron Oliveira, Professor · Professor

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2020-12-15
Completion
2020-12-15

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272229 on ClinicalTrials.gov