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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05254964
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Procedure: Cognitive rehabilitation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient
• Actual Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Feb 28, 2023
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive cognitive rehabilitation group Participants receive intensive cognitive rehabilitation for 20 hours for 4 weeks.	Procedure: Cognitive rehabilitation; Intensive cognitive rehabilitation by cognitive therapist for 1 hour on every working 20 days (4 weeks) during the subacute stroke phase

Outcome Measures

Primary Outcome Measures

1. Strength of connectivity in brain network obtained from MRI neuroimaging data [Change in strength of connectivity after intensive cognitive rehabilitation for 4 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yun-Hee Kim, Principal Investigator, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT05254964
• Other Study ID Numbers: 2021-12-019
• First Posted: Feb 24, 2022
• Last Update Posted: Feb 24, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Feb 24, 2022