Ignite Creation Date:
2024-05-06 @ 12:38 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03811626
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2019-01-18
Brief Title:
Efficacy of Multidimensional Management of Mild Traumatic Brain Injury
Sponsor:
Institut de Recherche sur la Moelle épinière et lEncéphale
Organization:
Institut de Recherche sur la Moelle épinière et lEncéphale
Study Overview
Official Title:
Efficacy of Multidimensional Management of Mild Traumatic Brain Injury A Randomised Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Unfavorable outcomes UO are seen in 15 to 20 of patients with mild traumatic brain injury mTBI Early identification of patients at risk for UO is crucial for suitable management to be initiated increasing their chances for a return to a normal life The investigators previously developed a diagnostic tool enabling early identification 8 to 21 days after the injury of patients likely to develop UO In the present study the investigators examined the value and beneficial effects of early multidimensional management MM on prognosis The investigators used a diagnostic tool to classify 221 mTBI patients as UO 97 or FO favorable outcome 124 Patients whose initial risk factors point to UO are at risk of developing post-concussion syndrome PCS UO patients were randomized into 2 groups a group that underwent MM cognitive-behavioral rehabilitation 34 and a group with no specific management 46 At 6 months these 2 groups were compared and the impact of MM on outcome was assessed Among patients initially classified as FO 101 95 had FO at 6 months and only 5 had PCS as defined by DSM-IV classification Of the UO patients who received MM 94 had no PCS 6 months after injury whereas 52 of the UO patients who did not receive MM had persistent PCS The effect of MM on the recovery of patients at 6 months once adjusted for the main confounding factors was statistically significant p0001 These results show that the initiation of MM after early identification of at-risk mTBI patients can considerably improves their prognosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None