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Study of Reserves After Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01628003
Recruitment Status : Unknown
Verified June 2012 by Sheba Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2012
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):

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:

  1. to determine whether such reserves exist.
  2. to study their convergent and discriminant validity.
  3. to study their characteristics.

Condition or disease Intervention/treatment
Traumatic Brain Injury Device: Brain MRI Device: MRI

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : August 2009
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: healthy persons Device: Brain MRI
Brain MRI
Device: MRI
Physical examination Neuropsychological testing Questionnaires
Experimental: patients after moderate-severe TBI Device: Brain MRI
Brain MRI
Device: MRI
Physical examination Neuropsychological testing Questionnaires


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628003


Locations
Israel
Sheba Tel Hashomer Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01628003     History of Changes
Other Study ID Numbers: SHEBA-09-7297-AS-CTIL
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

Keywords provided by Sheba Medical Center:
Traumatic Brain Injury
long-term outcome
Brain Reserves
Cognitive Reserves
Emotional Reserves
Patients 1 year or more after Moderate or Severe Traumatic Brain Injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System