- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01628003
Study of Reserves After Traumatic Brain Injury
June 25, 2012 updated by: Sheba Medical Center
Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ramat Gan, Israel, 52621
- Sheba Tel Hashomer Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: healthy persons
|
Brain MRI
Physical examination Neuropsychological testing Questionnaires
|
Experimental: patients after moderate-severe TBI
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Brain MRI
Physical examination Neuropsychological testing Questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
neuropsychological baterry for every participant will be performed during 3-4 meetings. An expected average for complete neuropsychological assessment is about 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
June 19, 2012
First Submitted That Met QC Criteria
June 25, 2012
First Posted (Estimate)
June 26, 2012
Study Record Updates
Last Update Posted (Estimate)
June 26, 2012
Last Update Submitted That Met QC Criteria
June 25, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-09-7297-AS-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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