StrokeNCT05519631
Correlates Between EEG Microstates and Clinical Characteristics of People With Stroke
An observational study of Stroke and Electroencephalogram, run by Federal University of Paraíba at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Electroencephalogram
- What is being tested?
- electroencephalogram
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2023to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- people over 18 years of age, regardless of sex and with a stroke confirmed by computed tomography or magnetic resonance imaging.
Who cannot join
- have other associated neurological pathology
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Aging and Neuroscience Studies Laboratory
João Pessoa
Suellen Andrade
About this study
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.
Read the 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.
- Conditions
- Stroke, Electroencephalogram
- Being tested
- electroencephalogram
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalogramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: electroencephalogram | |
| healthy | Only the EEG will be collected Receives: Other: electroencephalogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after evaluation
Secondary outcomes (2)
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.
Measured: Immediately after evaluation
Relationship between microstates and cognitive function
assessment of cognitive function - Montreal Cognitive Assessment (MoCA)
Measured: Immediately after evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start30 Jan 2023
- Primary completion30 May 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Andrade, Federal University of Paraíba
- Investigators
- Suellen Andrade, Dra, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519631
- Sponsor's protocol ID
- microstates_stroke_Obs
- Status last verified
- Apr 2023
- First submitted
- 4 Aug 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates Between EEG Microstates and Clinical Characteristics of People With Stroke
- ClinicalTrials.gov ID
- NCT05519631
- Acronym / sponsor ID
- microstates_stroke_Obs
- Conditions
- Stroke, Electroencephalogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| subacute stroke | – | Other: electroencephalogramParticipants 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. |
| chronic stroke | – | Other: electroencephalogramParticipants 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. |
| healthy | – | Other: electroencephalogramOnly the EEG will be collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- people over 18 years of age, regardless of sex and with a stroke confirmed by computed tomography or magnetic resonance imaging.
Key exclusion criteria (1 listed)
- have other associated neurological pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalogramThe 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. | Other | chronic stroke, healthy, subacute stroke |
Primary outcome
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.
2 secondary outcomes
Relationship between microstates and injury severity
Time frame: Immediately after evaluation
Relationship between microstates and cognitive function
Time frame: Immediately after evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suellen Andrade, Dra principal investigator
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Electroencephalogram, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LETICIA MARIA (81 993684588, leticiamaria.fisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eeg microstates (time frame: Immediately after evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.