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Study of Reserves After Traumatic Brain Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01628003
First received: June 19, 2012
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Traumatic Brain Injury
 Device: Brain MRI
Device: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: August 2009
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628003

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

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01628003     History of Changes
Other Study ID Numbers: SHEBA-09-7297-AS-CTIL
Study First Received: June 19, 2012
Last Updated: June 25, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013