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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05519631
Other study ID # microstates_stroke_Obs
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2023
Est. completion date September 20, 2023

Study information

Verified date April 2023
Source Federal University of Paraíba
Contact LETICIA MARIA
Phone 81 993684588
Email leticiamaria.fisio@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Stroke has been considered one of the main causes of long-term disability in the adult population, and is no longer considered a disease of the elderly, since 2/3 of all strokes occur among people under 70 years of age. According to the Ministry of Health, stroke is responsible for 40% of early retirements, being one of the most important causes of mortality in Brazil. The electroencephalogram (EEG) has been shown to be a very useful tool in the study of functional status and for the diagnosis of brain damage and disorders. It is considered a simple, non-invasive test with high temporal resolution, being a method widely used in laboratories to non-invasively monitor brain activity.


Description:

Stroke has been considered one of the main causes of long-term disability in the adult population, and is no longer considered a disease of the elderly, since 2/3 of all strokes occur among people under 70 years of age. According to the Ministry of Health, stroke is responsible for 40% of early retirements, being one of the most important causes of mortality in Brazil. Stroke usually causes long-term deficits such as asymmetrical muscle weakness between limbs, impaired proprioceptive ability, sensory loss, vision problems, and spasticity. In addition, these sensorimotor deficits interfere with various functions of the lower limbs, including balance, postural control, and gait ability, affecting their quality of life. The electroencephalogram (EEG) has been shown to be a very useful tool in the study of functional status and for the diagnosis of brain damage and disorders. It is considered a simple, non-invasive test with high temporal resolution, being a method widely used in laboratories to non-invasively monitor brain activity. Microstates reflect short periods (~100 ms) of nearly stable brain states evolving over time, resulting from the synchronous and coordinated activity of brain networks. The aim of this study is to observe whether EEG microstates have correlations with clinical characteristics of people with stroke.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date September 20, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - people over 18 years of age, regardless of sex and with a stroke confirmed by computed tomography or magnetic resonance imaging. Exclusion Criteria: - have other associated neurological pathology

Study Design


Related Conditions & MeSH terms


Intervention

Other:
electroencephalogram
The EEG is the recording of electrical activity in the brain in different regions of the cortex. The capture of electrical signals is performed by attaching electrodes to the surface of the scalp. As the EEG signal has an amplitude in microvolts (µVpp) it is necessary to use amplifiers, leaving the signal possible to be registered. The electrode-electrolyte interface is very important and must be able to provide a good connection between the skin and the conductive material of the electrode, otherwise the EEG signal, in addition to being contaminated by noise, may suffer distortion.

Locations

Country Name City State
Brazil Aging and Neuroscience Studies Laboratory Joao Pessoa

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary eeg microstates We will determine the number of topographic maps using a pre-determined criterion of the four "classical" maps (A, B, C and D) and classify the continuous EEG data according to the topographic map with which a given stretch has the highest correlation. Immediately after evaluation
Secondary Relationship between microstates and injury severity They were evaluated with the National Institute of Health Stroke Scale (NIHSS) to quantify the severity and magnitude of the neurological deficit after the stroke. Immediately after evaluation
Secondary Relationship between microstates and cognitive function assessment of cognitive function - Montreal Cognitive Assessment (MoCA) Immediately after evaluation
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