NCT05519631

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

August 4, 2022

Last Update Submit

April 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Relationship between microstates and injury severity

    Immediately after evaluation

  • Relationship between microstates and cognitive function

    Immediately after evaluation

Study Arms (3)

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.

Other: electroencephalogram

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.

Other: electroencephalogram

healthy

Only the EEG will be collected

Other: electroencephalogram

Interventions

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 strokehealthysubacute stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • people over 18 years of age, regardless of sex and with a stroke confirmed by computed tomography or magnetic resonance imaging.

You may not qualify if:

  • have other associated neurological pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aging and Neuroscience Studies Laboratory

João Pessoa, Brazil

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Suellen Andrade, Dra

    Federal University of Paraiba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 29, 2022

Study Start

January 30, 2023

Primary Completion

May 30, 2023

Study Completion

September 20, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations