Overview

This trial is active, not recruiting.

Condition traumatic brain injury
Treatments brain mri, mri
Sponsor Sheba Medical Center
Start date August 2009
End date January 2014
Trial size 240 participants
Trial identifier NCT01628003, SHEBA-09-7297-AS-CTIL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
brain mri
Brain MRI
mri
Physical examination Neuropsychological testing Questionnaires
(Experimental)
brain mri
Brain MRI
mri
Physical examination Neuropsychological testing Questionnaires

Primary Outcomes

Measure
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

Male or female participants from 19 years up to 80 years old.

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

Additional Information

Official title Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Sheba Medical Center.