ClinicalTrials.gov
ClinicalTrials.gov Menu

Recovery Prediction of Motor Function Using Neuroimaging Techniques in Subacute Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03365596
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Brief Summary:
Prediction of recovery from stroke can assist in the planning of impairment-focused rehabilitation. To achieve better prediction for clinical purposes, this study investigated a new prediction model with low inter-individual variability and high accuracy using neuroimaging techniques.

Condition or disease Intervention/treatment Phase
Stroke Other: Conventional therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Functional MRI and DTI Study for Brain Network Analysis and Recovery Prediction in Subacute Stroke Patients
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Subacute stroke Other: Conventional therapy
According to the status of a patient, optimized therapy will be applied.




Primary Outcome Measures :
  1. Fugl-Meyer Assessment score at 3 months after stroke onset [ Time Frame: 3 months after stroke onset ]
    Measurement of motor function of upper and lower extremities



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • First-ever stroke patients
  • Subacute stage (less than 4 weeks)
  • Total Fugl-Meyer Assessment (FMA) score under between 9 and 79.

Exclusion Criteria:

  • Major active neurological disease or psychiatric disease
  • A history of seizure
  • Metallic implants in their brain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365596


Contacts
Contact: Yun-Hee Kim, MD, PhD +82-2-3410-2818 yun1225.kim@samsung.com
Contact: Jungsoo Lee, PhD +82-2-3410-3762 jungsoo0319@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Yun-Hee Kim, MD, PhD    82-2-3410-2824    yunkim@skku.edu   
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03365596     History of Changes
Other Study ID Numbers: 2017-02-107
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Samsung Medical Center:
Brain connectivity
Magnetic resonance imaging
Recovery prediction

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases