NCT01628003

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. 1.to determine whether such reserves exist.
  2. 2.to study their convergent and discriminant validity.
  3. 3.to study their characteristics.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

4.4 years

First QC Date

June 19, 2012

Last Update Submit

June 25, 2012

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injurylong-term outcomeBrain ReservesCognitive ReservesEmotional ReservesPatients 1 year or more after Moderate or Severe Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological battery

    neuropsychological baterry for every participant will be performed during 3-4 meetings. An expected average for complete neuropsychological assessment is about 8 weeks

Study Arms (2)

healthy persons

ACTIVE COMPARATOR
Device: Brain MRIDevice: MRI

patients after moderate-severe TBI

EXPERIMENTAL
Device: Brain MRIDevice: MRI

Interventions

Brain MRIDEVICE

Brain MRI

healthy personspatients after moderate-severe TBI
MRIDEVICE

Physical examination Neuropsychological testing Questionnaires

healthy personspatients after moderate-severe TBI

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Tel Hashomer Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 26, 2012

Study Start

August 1, 2009

Primary Completion

January 1, 2014

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations

IL(1)