MR Imaging Study of TBI in Children | NCT03034031

Studies
MR Imaging Study of TBI in Children

NCT03034031

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Nov 24, 2023Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

TBI (Traumatic Brain Injury)

Interventions

Not provided

Countries

Israel

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2018Actual

Primary Completion Date

Oct 2024Estimated

Completion Date

Oct 2025Estimated

First Submitted Date

Jan 25, 2017

First Submission Date that Met QC Criteria

Jan 25, 2017

First Posted Date

Jan 27, 2017Estimated

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

Nov 22, 2023

Last Update Posted Date

Nov 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Abigail livny-ezer, Head of functional neuromaging lab, Department of Diagnostic Imaging, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This project will combine the data collected from structural and functional MRI scans and neuropsychology performance post-TBI in children. Patients will be followed for a year, in order to examine the brain and cognitive recovery post head injury.

Detailed Description

Traumatic brain injury in childhood has an cumulative effect that leads to impairments in cognitive functions such as deficits in memory, executive functions and attention. The cognitive impairment is the main cause of disabilities in the injured population, and has a different effect depending on the type and severity of the injury.

Imaging after brain trauma serves as a useful diagnostic tool in identifying the head trauma's results. Therefore, in recent years, using imaging methods, studies have tried to find measures which will be able to predict the functional outcome after brain injury in children, and assist in developing a personalized rehabilitation program. The combination of advanced imaging techniques with neuropsychological assessment within the early stage of the injury and during a year of followup, will allow us to establish the relationship between those measures and the functional recovery result of the children. This multi-analysis will enable us to have a deeper understanding of the neuroplasticity process and the functional recovery after brain injury in the developing young brain.

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

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional MRI	fMRI brain activation to a cognitive tasks	12 months
Structural MRI	MRI Structural changes using different methods	12 months
neuropsychological tests	Cognitive scores on neuropsychological testing	12 months

Secondary Outcomes

Measure	Description	Time Frame
Associations between the cognitive performance and the imaging methods		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 9-18 years old, which are/were hospitalized in the Pediatric Rehabilitation Department, Sheba Medical Center
Glasgow coma scale score of 3-15.
Hebrew as mother-tongue

Exclusion Criteria:

History of neurological disorders, mental retardation or a previous head injury.
Current diagnosis or history of psychiatric disorders.
Cardiovascular instability.
Metabolic instability (water, electrolytes, sugar).
Fever or evidence of microbiological pollutant.
Uncontrolled seizures. 7 . Hydrocephalus.

8. Deafness or blindness. 9. Renal failure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

study population will include 1 group of subjects: group 1: young subjects, age 9-18, after traumatic brain injury

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abigail Livny-Ezer, PhD	Contact	+972549988058		abigail.livnyezer@gmail.com
Tamar Silberg, PhD	Contact	+972507693933		tamarsilberg@gmail.com

Overall Officials

Name	Affiliation	Role
Abigail Livny-Ezer, PhD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba medical center Tel Hashomer	Recruiting	Ramat Gan			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27750571	Background	Livny A, Biegon A, Kushnir T, Harnof S, Hoffmann C, Fruchter E, Weiser M. Cognitive Deficits Post-Traumatic Brain Injury and Their Association with Injury Severity and Gray Matter Volumes. J Neurotrauma. 2017 Apr 1;34(7):1466-1472. doi: 10.1089/neu.2016.4598. Epub 2016 Dec 2.
12759820	Background	Anderson VA, Anderson P, Northam E, Jacobs R, Mikiewicz O. Relationships between cognitive and behavioral measures of executive function in children with brain disease. Child Neuropsychol. 2002 Dec;8(4):231-40. doi: 10.1076/chin.8.4.231.13509.

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases