NCT03034031

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 24, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

6.3 years

First QC Date

January 25, 2017

Last Update Submit

November 22, 2023

Conditions

TBI (Traumatic Brain Injury)

Keywords

Traumatic Brain InjuryChildrenPediatricMRIfMRICognitionDTILongitudinalConnectivityDAINeuropsychologyRehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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 (1)

  • Associations between the cognitive performance and the imaging methods

    12 months

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • \. Deafness or blindness. 9. Renal failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center Tel Hashomer

Ramat Gan, Israel

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27750571BACKGROUND

  • 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.

    PMID: 12759820BACKGROUND

  • Anderson V, Catroppa C. Recovery of executive skills following paediatric traumatic brain injury (TBI): a 2 year follow-up. Brain Inj. 2005 Jun;19(6):459-70. doi: 10.1080/02699050400004823.

    PMID: 16101268BACKGROUND

  • Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J. Recovery of intellectual ability following traumatic brain injury in childhood: impact of injury severity and age at injury. Pediatr Neurosurg. 2000 Jun;32(6):282-90. doi: 10.1159/000028956.

    PMID: 10971189BACKGROUND

  • Keightley ML, Sinopoli KJ, Davis KD, Mikulis DJ, Wennberg R, Tartaglia MC, Chen JK, Tator CH. Is there evidence for neurodegenerative change following traumatic brain injury in children and youth? A scoping review. Front Hum Neurosci. 2014 Mar 19;8:139. doi: 10.3389/fnhum.2014.00139. eCollection 2014.

    PMID: 24678292BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Abigail Livny-Ezer, PhD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Livny-Ezer, PhD

CONTACT

+972549988058abigail.livnyezer@gmail.com

Tamar Silberg, PhD

CONTACT

+972507693933tamarsilberg@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of functional neuromaging lab, Department of Diagnostic Imaging

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

June 24, 2018

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

IL(1)