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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05254964
Other study ID # 2021-12-019
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date February 28, 2023

Study information

Verified date March 2023
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Altered brain networks, including cognitive, motor, and language networks, are investigated by intensive cognitive rehabilitation in subacute stroke patients.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria: - Patients aged 19 to 80 years - Patients with subacute stroke within 2 weeks of onset - First-ever stroke - Supratentorial stroke - Less than 8 SAFE (shoulder abduction, finger extension) points - Less than 35 FMA Upper scores - MEP (motor evoked potential) negative - Not more than 24 K-MMSE (Korean Mini-Mental State Examination) score Exclusion Criteria: - Difficult to communicate due to severe language impairment. - Accompanied by an existing serious neurogenic disease - Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder - If there are difficulties in conducting the research - Any patients who are judged by the investigator to be difficult to participate in this study - Patients with contraindicated MRI scans

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cognitive rehabilitation
Intensive cognitive rehabilitation by cognitive therapist for 1 hour on every working 20 days (4 weeks) during the subacute stroke phase

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Strength of connectivity in brain network obtained from MRI neuroimaging data Participants' MRI neuroimaging data are acquired at pre- and post-intervention. Brain network can be constructed using MRI neuroimaging data, and strength of connectivity can be calculated in the brain network. Strength of connectivity has a value between -1 and 1. Change in strength of connectivity after intensive cognitive rehabilitation for 4 weeks
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