Cognitive Function and Autonomic Regulation in Patients With Migraine

Migraine Disorders Clinical Trial

Official title:

Cognitive Function and Autonomic Regulation in Patients With Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272229
• Other study ID #: 3.741.233
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: April 2021
• Source: Fortaleza University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Migraine diagnosis

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	University of Fortaleza	Fortaleza	Ceara

Sponsors (1)

Lead Sponsor	Collaborator
Fortaleza University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Attention and concentration test	Concentration and attention will be recorded during the cognition test	one week
Primary	Sympathetic activation	Sympathetic nervous system will be recorded by R-R intervals	one week