TBI (Traumatic Brain Injury)MISTICNCT03034031
MR Imaging Study of TBI in Children
An observational study of TBI (Traumatic Brain Injury), run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Jun 2018to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: study population will include 1 group of subjects: group 1: young subjects, age 9-18, after traumatic brain injury
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center Tel Hashomer
Ramat Gan
Reut Moran, MsC, +972523532982, reutim007@gmail.com
About this study
Official title: Classifying Neuro-imaging Measures Predicting Rehabilitation Outcome Following Pediatric Closed Head Injuries.
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.
Read the 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.
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- Traumatic Brain Injury, Children, Pediatric, MRI, fMRI, Cognition, DTI, Longitudinal, Connectivity, DAI, Neuropsychology, Rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional MRI
fMRI brain activation to a cognitive tasks
Measured: 12 months
Structural MRI
MRI Structural changes using different methods
Measured: 12 months
neuropsychological tests
Cognitive scores on neuropsychological testing
Measured: 12 months
Secondary outcomes (1)
Associations between the cognitive performance and the imaging methods
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start24 Jun 2018
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Abigail livny-ezer, Sheba Medical Center
- Investigators
- Abigail Livny-Ezer, PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034031
- Sponsor's protocol ID
- 3211-16-SMC
- Acronym
- MISTIC
- Status last verified
- Nov 2023
- First submitted
- 25 Jan 2017
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27750571Anderson 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.
PubMed 12759820Anderson 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.
PubMed 16101268Anderson 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.
PubMed 10971189Keightley 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.
PubMed 24678292
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classifying Neuro-imaging Measures Predicting Rehabilitation Outcome Following Pediatric Closed Head Injuries.
- ClinicalTrials.gov ID
- NCT03034031
- Acronym / sponsor ID
- MISTIC / 3211-16-SMC
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- Traumatic Brain Injury, Children, Pediatric, MRI, fMRI, Cognition, DTI, Longitudinal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 24 Jun 2018 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- study population will include 1 group of subjects: group 1: young subjects, age 9-18, after traumatic brain injury
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional MRI
Time frame: 12 months
fMRI brain activation to a cognitive tasks
Structural MRI
Time frame: 12 months
MRI Structural changes using different methods
neuropsychological tests
Time frame: 12 months
Cognitive scores on neuropsychological testing
1 secondary outcome
Associations between the cognitive performance and the imaging methods
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 27750571Livny 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.
- Background: PubMed 12759820Anderson 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.
- Background: PubMed 16101268Anderson 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.
- Background: PubMed 10971189Anderson 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.
- Background: PubMed 24678292Keightley 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.
- Individual participant dataSharing planned: Undecided
Related trials for TBI (Traumatic Brain Injury)
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail Livny-Ezer, PhD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI (Traumatic Brain Injury), run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abigail Livny-Ezer, PhD (+972549988058, abigail.livnyezer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional MRI (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03034031, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.