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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05499442
Other study ID # haojunwei8
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2023

Study information

Verified date August 2022
Source Xuanwu Hospital, Beijing
Contact Junwei Hao
Phone 01083199088
Email haojunwei@vip.163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 31, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. First onset. 3. Age = 18 years old. 4. Motor dysfunction of upper and / or lower limbs: muscle strength decreased by 0 to 5-grade and / or ataxia. 5. Informed consent has been signed. Exclusion Criteria: 1. Vital signs are unstable. 2. 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. 3. Functional impairment of upper or lower limbs caused by other diseases of nervous system or other reasons, such as fracture, deformity, etc. 4. Unable to cooperate to complete the examination, such as mental disorder, cognitive impairment, visual impairment, sitting balance disorder, etc 5. Other reasons: alcoholism; Skull defect; Head skin defect, etc.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Xuanwu Hospital, Beijing Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary EEG characteristics of motor EEG Characteristics for Motor Execution and Motor Imagery 1-7day
Primary Action Research Arm Test Use the assessment scale of Action Research Arm Test evaluation completes the limb function evaluation 1-7days
Primary Fugl-meyer Assessment Use the assessment scale of Fuel-meyer to evaluate completes the limb function evaluation 1-7days
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