- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05519631
Correlates Between EEG Microstates and Clinical Characteristics of People With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: LETICIA MARIA
- Phone Number: 81 993684588
- Email: leticiamaria.fisio@gmail.com
Study Locations
-
-
-
Joao Pessoa, Brazil
- Recruiting
- Aging and Neuroscience Studies Laboratory
-
Contact:
- Suellen Andrade
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
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
Sponsor
Investigators
- Principal Investigator: Suellen Andrade, Dra, Federal University of Paraíba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- microstates_stroke_Obs
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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