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Study of Reserves After Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Brain MRI
MRI
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, long-term outcome, Brain Reserves, Cognitive Reserves, Emotional Reserves, Patients 1 year or more after Moderate or Severe Traumatic Brain Injury

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Moderate-Severe Traumatic Brain Injury according to at least 1 the following:

    • Duration of loss of consciousness (LOC) - more then 1/2 hour
    • Glasgow Coma Scale (GCS) - less then 13
    • Post Traumatic Amnesia (PTA) - more then 24 hours.
  • At least 1 year after the injury.

Exclusion Criteria:

  • Mild Traumatic Brain Injury
  • the present state of Post Traumatic Amnesia
  • dementia
  • the age less than 18 years on the moment of injury
  • less than 1 year since the injury
  • incapacity of the patient to cooperate in the study (incapacity of any source including physical, mental, and language problems)
  • premorbid diagnosis of Mental Retardation

Sites / Locations

  • Sheba Tel Hashomer Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

healthy persons

patients after moderate-severe TBI

Arm Description

Outcomes

Primary Outcome Measures

Neuropsychological battery

Secondary Outcome Measures

Full Information

First Posted
June 19, 2012
Last Updated
June 25, 2012
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01628003
Brief Title
Study of Reserves After Traumatic Brain Injury
Official Title
Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It is hypothesized that the long-term results of rehabilitation and subsequent aging after Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive, emotional) reserves. The purpose of this study are: to determine whether such reserves exist. to study their convergent and discriminant validity. to study their characteristics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, long-term outcome, Brain Reserves, Cognitive Reserves, Emotional Reserves, Patients 1 year or more after Moderate or Severe Traumatic Brain Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy persons
Arm Type
Active Comparator
Arm Title
patients after moderate-severe TBI
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Brain MRI
Intervention Description
Brain MRI
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
Physical examination Neuropsychological testing Questionnaires
Primary Outcome Measure Information:
Title
Neuropsychological battery
Time Frame
neuropsychological baterry for every participant will be performed during 3-4 meetings. An expected average for complete neuropsychological assessment is about 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Moderate-Severe Traumatic Brain Injury according to at least 1 the following: Duration of loss of consciousness (LOC) - more then 1/2 hour Glasgow Coma Scale (GCS) - less then 13 Post Traumatic Amnesia (PTA) - more then 24 hours. At least 1 year after the injury. Exclusion Criteria: Mild Traumatic Brain Injury the present state of Post Traumatic Amnesia dementia the age less than 18 years on the moment of injury less than 1 year since the injury incapacity of the patient to cooperate in the study (incapacity of any source including physical, mental, and language problems) premorbid diagnosis of Mental Retardation
Facility Information:
Facility Name
Sheba Tel Hashomer Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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Study of Reserves After Traumatic Brain Injury

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