Study of Reserves After Traumatic Brain Injury

NCT ID: NCT01628003

Last Updated: 2012-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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healthy persons

Group Type ACTIVE_COMPARATOR

Brain MRI

Intervention Type DEVICE

Brain MRI

MRI

Intervention Type DEVICE

Physical examination Neuropsychological testing Questionnaires

patients after moderate-severe TBI

Group Type EXPERIMENTAL

Brain MRI

Intervention Type DEVICE

Brain MRI

MRI

Intervention Type DEVICE

Physical examination Neuropsychological testing Questionnaires

Interventions

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Brain MRI

Brain MRI

Intervention Type DEVICE

MRI

Physical examination Neuropsychological testing Questionnaires

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sheba Tel Hashomer Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-09-7297-AS-CTIL

Identifier Type: -

Identifier Source: org_study_id

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