Study of Reserves After Traumatic Brain Injury | NCT01628003

Studies
Study of Reserves After Traumatic Brain Injury

NCT01628003

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jun 26, 2012Estimated

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Traumatic Brain Injury

Interventions

Brain MRI
MRI

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jan 2014Estimated

Completion Date

Not provided

First Submitted Date

Jun 19, 2012

First Submission Date that Met QC Criteria

Jun 25, 2012

First Posted Date

Jun 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2012

Last Update Posted Date

Jun 26, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy persons	Active Comparator		Device: Brain MRI Device: MRI
patients after moderate-severe TBI	Experimental		Device: Brain MRI Device: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brain MRI	Device	Brain MRI	healthy persons patients after moderate-severe TBI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Tel Hashomer Medical Center		Ramat Gan		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided