Acute StrokeNCT05499442
EEG Motor Movement and Imagery Dataset for Stroke
An observational study of Acute Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The investigators collect and analyze the alpha and beta wave of EEG activity at the motor cortices of the participants, When the motor task is being performed. The Brodmann area 10-20 method and portable EEG equipment was used in the single-center study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with motor dyfunction in Xuanwu Hospital of Capital Medical University were admitted from January 1, 2022 to December 31, 2023
Who may be able to join
- The diagnosis of cerebral infarction conforms to the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018, and the diagnosis of intracerebral hemorrhage conforms to the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of intracerebral hemorrhage 2019.
- First onset.
- Age ≥ 18 years old.
- Motor dysfunction of upper and / or lower limbs: muscle strength decreased by 0 to 5-grade and / or ataxia.
- Informed consent has been signed.
Who cannot join
- Vital signs are unstable.
- Serious circulatory system, respiratory system, motor system and other diseases, such as atrial fibrillation, heart failure, pulmonary infection, severe liver and kidney insufficiency, lower extremity venous thrombosis and other serious diseases.
- Functional impairment of upper or lower limbs caused by other diseases of nervous system or other reasons, such as fracture, deformity, etc.
- Unable to cooperate to complete the examination, such as mental disorder, cognitive impairment, visual impairment, sitting balance disorder, etc
- Other reasons: alcoholism; Skull defect; Head skin defect, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, 100053
Junwei Hao, MD,Ph.D, 010-83199089, haojunwei@vip.163.com
Haijie Liu, MD,Ph.D, 010-83199089, hongyanli09@126.com
About this study
Official title: Construction of Non-invasive EEG Motor Movement and Imagery Dataset for Stroke
The investigators collect and analyze the alpha and beta wave of EEG activity at the motor cortices of the participants, When the motor task is being performed. The Brodmann area 10-20 method and portable EEG equipment was used in the single-center study.
Read the detailed description
To understand the motor mechanism of stroke patients with motor dysfunction, an EEG motor movement and imagery dataset for Stroke will be created. 120 subjects will be enrolled in the single-center study. The investigators collect and analyze the EEG activity at the motor cortices of the participants, When the motor movement or imagery task is being performed. The alpha and beta wave of EEGs were recorded from 32 electrodes as per the international 10-20 system with portable EEG equipment.
- Conditions
- Acute Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG characteristics of motor
EEG Characteristics for Motor Execution and Motor Imagery
Measured: 1-7day
Action Research Arm Test
Use the assessment scale of Action Research Arm Test evaluation completes the limb function evaluation
Measured: 1-7days
Fugl-meyer Assessment
Use the assessment scale of Fuel-meyer to evaluate completes the limb function evaluation
Measured: 1-7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Jan 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junwei Hao, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499442
- Sponsor's protocol ID
- haojunwei8
- Status last verified
- Aug 2022
- First submitted
- 1 Apr 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Non-invasive EEG Motor Movement and Imagery Dataset for Stroke
- ClinicalTrials.gov ID
- NCT05499442
- Acronym / sponsor ID
- haojunwei8
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 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.
The investigators collect and analyze the alpha and beta wave of EEG activity at the motor cortices of the participants, When the motor task is being performed. The Brodmann area 10-20 method and portable EEG equipment was used in the single-center study.
Detailed description
To understand the motor mechanism of stroke patients with motor dysfunction, an EEG motor movement and imagery dataset for Stroke will be created. 120 subjects will be enrolled in the single-center study. The investigators collect and analyze the EEG activity at the motor cortices of the participants, When the motor movement or imagery task is being performed. The alpha and beta wave of EEGs were recorded from 32 electrodes as per the international 10-20 system with portable EEG equipment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with motor dyfunction in Xuanwu Hospital of Capital Medical University were admitted from January 1, 2022 to December 31, 2023
Key inclusion criteria (5 listed)
- The diagnosis of cerebral infarction conforms to the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018, and the diagnosis of intracerebral hemorrhage conforms to the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of intracerebral hemorrhage 2019.
- First onset.
- Age ≥ 18 years old.
- Motor dysfunction of upper and / or lower limbs: muscle strength decreased by 0 to 5-grade and / or ataxia.
- Informed consent has been signed.
Key exclusion criteria (5 listed)
- Vital signs are unstable.
- Serious circulatory system, respiratory system, motor system and other diseases, such as atrial fibrillation, heart failure, pulmonary infection, severe liver and kidney insufficiency, lower extremity venous thrombosis and other serious diseases.
- Functional impairment of upper or lower limbs caused by other diseases of nervous system or other reasons, such as fracture, deformity, etc.
- Unable to cooperate to complete the examination, such as mental disorder, cognitive impairment, visual impairment, sitting balance disorder, etc
- Other reasons: alcoholism; Skull defect; Head skin defect, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EEG characteristics of motor
Time frame: 1-7day
EEG Characteristics for Motor Execution and Motor Imagery
Action Research Arm Test
Time frame: 1-7days
Use the assessment scale of Action Research Arm Test evaluation completes the limb function evaluation
Fugl-meyer Assessment
Time frame: 1-7days
Use the assessment scale of Fuel-meyer to evaluate completes the limb function evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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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.
Junwei Hao principal investigator
Xuanwu Hospital, Beijing
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 Acute Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
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 5 inclusion and 5 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 12 Aug 2022. 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 China. 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 Junwei Hao (01083199088, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG characteristics of motor (time frame: 1-7day). The study lists 3 primary outcomes in all. 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 12 Aug 2022.