search
Back to results

Cognitive Function and Autonomic Regulation in Patients With Migraine

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cognition
Sympathetic Nervous System
Concentratio and Attention
Sponsored by
Fortaleza University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Migraine Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Migraine diagnosis

Exclusion Criteria:

  • Previous stroke
  • Type I or II diabetes
  • Heart disease
  • vascular diseases
  • previous cognition impairment
  • mental disorders
  • color blindness

Sites / Locations

  • University of Fortaleza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Migrain Group

Arm Description

Cognitive 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.

Cognitive 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.

Outcomes

Primary Outcome Measures

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.
Attention and concentration test
Concentration and attention will be recorded during the cognition test
Sympathetic activation
Sympathetic nervous system will be recorded by R-R intervals

Secondary Outcome Measures

Full Information

First Posted
February 12, 2020
Last Updated
April 27, 2021
Sponsor
Fortaleza University
search

1. Study Identification

Unique Protocol Identification Number
NCT04272229
Brief Title
Cognitive Function and Autonomic Regulation in Patients With Migraine
Official Title
Cognitive Function and Autonomic Regulation in Patients With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fortaleza University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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®.
Detailed Description
The sympathetic nervous system is responsible for responding to stressful situations with involuntary actions, which will increase the neuronal activity in order to maintain body homeostasis. Stress is one of the most common causes of migraines. When it occurs for a prolonged period, there will be an over-stimulation of the sympathetic nervous system that will lead to dysautonomia, generating the rapid consumption of the neurotransmitter norepinephrine at the same time that adenosine, dopamine. It is believed that before the headache, the levels of norepinephrine are elevated, causing a vasoconstriction of extracranial vascularization, followed by a vasodilation resulting from the release of the other hormones previously mentioned, thus instituting the painful phase of migraine. Thus, migraine acts on the vascular system through changes in its homeostasis, predisposing the occurrence of future ischemic and/or hemorrhagic episodes to the brain and cardiac levels. The disruption of this system with the multifactorial mechanisms of migraine manifestation can then result in an increased risk of coronary heart disease and other changes in cardiac functioning, acquiring highly harmful potential for the human body. The interest in this study started in view of the numerous uncertainties within the scientific sphere regarding the possible systemic impacts caused by migraines after detailed research on the subject. The same becomes relevant, as it will contribute to the development of knowledge about headaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Cognitive 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.
Arm Title
Migrain Group
Arm Type
Experimental
Arm Description
Cognitive 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cognition
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sympathetic Nervous System
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Concentratio and Attention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognition
Description
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.
Time Frame
one week
Title
Attention and concentration test
Description
Concentration and attention will be recorded during the cognition test
Time Frame
one week
Title
Sympathetic activation
Description
Sympathetic nervous system will be recorded by R-R intervals
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Migraine diagnosis Exclusion Criteria: Previous stroke Type I or II diabetes Heart disease vascular diseases previous cognition impairment mental disorders color blindness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayron Oliveira, Professor
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Fortaleza
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60811-905
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Function and Autonomic Regulation in Patients With Migraine

We'll reach out to this number within 24 hrs