Factors Related to Functional Recovery Using Brain Imagin... | NCT03632070

Studies
Factors Related to Functional Recovery Using Brain Imaging of Stroke Patients

NCT03632070

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Sep 4, 2020Actual

Enrollment

73Actual

Phase

Not provided

Conditions

Stroke

Interventions

Data acquisition of functional abilities

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 9, 2018Actual

Primary Completion Date

Aug 24, 2020Actual

Completion Date

Aug 24, 2020Actual

First Submitted Date

Aug 13, 2018

First Submission Date that Met QC Criteria

Aug 13, 2018

First Posted Date

Aug 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2020

Last Update Posted Date

Sep 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, brain imaging predictive factors related to motor recovery will be investigated. Lastly, the prediction model will be established.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stroke		Patients with ischemic or hemorrhagic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine	Behavioral: Data acquisition of functional abilities

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data acquisition of functional abilities	Behavioral	MRI data, motor evoked potentials, and behavior data acquisition	Stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugl-Meyer Assessment score at 3 months after stroke onset	Measurement of motor function of upper and lower extremities	3 months after stroke onset]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults more than 19 years
First-ever unilateral stroke
Ischemic subacute stroke patients

Exclusion Criteria:

Major active neurological disease or psychiatric disease
Metallic implants in their brain
Hemorrhagic stroke
Bilateral lesions
Recurrent stroke

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with ischemic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		06351	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided