NCT05254964

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

February 9, 2022

Last Update Submit

March 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Intensive cognitive rehabilitation group

EXPERIMENTAL

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

Procedure: Cognitive rehabilitation

Interventions

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

Intensive cognitive rehabilitation group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 24, 2022

Study Start

February 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations