Study of Reserves After Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01628003
• Other study ID #: SHEBA-09-7297-AS-CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: June 19, 2012
• Last updated: June 25, 2012
• Start date: August 2009

Study information

• Verified date: June 2012
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Device:
• Brain MRI
Brain MRI
• MRI
Physical examination Neuropsychological testing Questionnaires

Locations

Country	Name	City	State
Israel	Sheba Tel Hashomer Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No