Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
Study NCT ID:
NCT04364568
Status:
TERMINATED
Last Update Posted:
2024-05-28
First Post:
2020-03-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty recruiting and no sociologists
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRACE
Brief Summary:
Minor traumatic brain injury (mTBI) (Glasgow Coma Scale 13 to 15) represent 70 to 90% of traumatic brain injury. Different disorders may occur after a traumatic minor brain injury (somatic, cognitive or affective) within 2 weeks.
For 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Today a small amount of tools to predict this syndrome are available. Cerebral CT scan, a routine test for mTBI, isn't relevant to predict the post concussion syndrome.
In order to improve understanding of the evolution toward this complication, it seems relevant to run a multimodal study.
Multiparameter MRI combined to psychological and sociological evaluations cold provide a better global perception.
For 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Today a small amount of tools to predict this syndrome are available. Cerebral CT scan, a routine test for mTBI, isn't relevant to predict the post concussion syndrome.
In order to improve understanding of the evolution toward this complication, it seems relevant to run a multimodal study.
Multiparameter MRI combined to psychological and sociological evaluations cold provide a better global perception.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: