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Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient

Primary Purpose

Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cognitive rehabilitation
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intensive cognitive rehabilitation group

Arm Description

Participants receive intensive cognitive rehabilitation for 20 hours for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2022
Last Updated
March 5, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05254964
Brief Title
Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient
Official Title
Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Patients not recruited.
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive cognitive rehabilitation group
Arm Type
Experimental
Arm Description
Participants receive intensive cognitive rehabilitation for 20 hours for 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
Cognitive rehabilitation
Intervention Description
Intensive cognitive rehabilitation by cognitive therapist for 1 hour on every working 20 days (4 weeks) during the subacute stroke phase
Primary Outcome Measure Information:
Title
Strength of connectivity in brain network obtained from MRI neuroimaging data
Description
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.
Time Frame
Change in strength of connectivity after intensive cognitive rehabilitation for 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient

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