Correlates Between EEG Microstates and Clinical Characteristics of People With Stroke

April 28, 2023 updated by: Suellen Andrade, Federal University of Paraíba
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.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Joao Pessoa, Brazil
        • Recruiting
        • Aging and Neuroscience Studies Laboratory
        • Contact:
          • Suellen Andrade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The sample consisted of 45 people, 15 individuals with subacute stroke, 15 individuals with chronic stroke and 15 healthy controls, selected for convenience. Stroke subjects were recruited through personal invitations from individuals admitted to a hospital's neurology outpatient clinic.

Individuals matched by sex and age, with no history of neurological or psychiatric diseases, were recruited to the control group.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
subacute stroke
Participants were evaluated for clinical outcome before the electroencephalogram examination. They were evaluated with the National Institute of Health Stroke Scale (NIHSS) to quantify the severity and magnitude of neurological deficit after stroke and by the Montreal Cognitive Assessment (MoCA) to assess cognitive function.
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.
chronic stroke
Participants were evaluated for clinical outcome before the electroencephalogram examination. They were evaluated with the National Institute of Health Stroke Scale (NIHSS) to quantify the severity and magnitude of neurological deficit after stroke and by the Montreal Cognitive Assessment (MoCA) to assess cognitive function.
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.
healthy
Only the EEG will be collected
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eeg microstates
Time Frame: Immediately after evaluation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between microstates and injury severity
Time Frame: Immediately after evaluation
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
Relationship between microstates and cognitive function
Time Frame: Immediately after evaluation
assessment of cognitive function - Montreal Cognitive Assessment (MoCA)
Immediately after evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Suellen Andrade, Dra, Federal University of Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

September 20, 2023

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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