Study of Reserves After Traumatic Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Sheba Medical Center.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 26, 2014