MR Imaging Study of TBI in Children

TBI (Traumatic Brain Injury) Clinical Trial

— MISTIC  

Official title:

Classifying Neuro-imaging Measures Predicting Rehabilitation Outcome Following Pediatric Closed Head Injuries.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03034031
• Other study ID #: 3211-16-SMC
• Status: Recruiting
• Start date: June 24, 2018
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: Sheba Medical Center
• Contact: Abigail Livny-Ezer, PhD
• Phone: +972549988058
• Email: abigail.livnyezer[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Patients 9-18 years old, which are/were hospitalized in the Pediatric Rehabilitation Department, Sheba Medical Center

2. Glasgow coma scale score of 3-15.

3. Hebrew as mother-tongue

Exclusion Criteria:

1. History of neurological disorders, mental retardation or a previous head injury.

2. Current diagnosis or history of psychiatric disorders.

3. Cardiovascular instability.

4. Metabolic instability (water, electrolytes, sugar).

5. Fever or evidence of microbiological pollutant.

6. Uncontrolled seizures. 7 . Hydrocephalus.

8. Deafness or blindness. 9. Renal failure.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)

Locations

Country	Name	City	State
Israel	Sheba medical center Tel Hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional MRI	fMRI brain activation to a cognitive tasks	12 months
Primary	Structural MRI	MRI Structural changes using different methods	12 months
Primary	neuropsychological tests	Cognitive scores on neuropsychological testing	12 months
Secondary	Associations between the cognitive performance and the imaging methods		12 months