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Clinical Trials/NCT01628003
NCT01628003
Unknown
Not Applicable

Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury

Sheba Medical Center1 site in 1 country240 target enrollmentAugust 2009
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ConditionsTraumatic Brain Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Sheba Medical Center
Enrollment
240
Locations
1
Primary Endpoint
Neuropsychological battery
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.
Registry
clinicaltrials.gov
Start Date
August 2009
End Date
January 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • •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

Outcomes

Primary Outcomes

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

Study Sites (1)

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