Study of Reserves After Traumatic Brain Injury

Sheba Medical Center

Status: Unknown

Conditions: Traumatic Brain Injury

Treatments: Device: MRI; Device: Brain MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01628003

SHEBA-09-7297-AS-CTIL

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

healthy persons

Active Comparator group

Treatment:

Device: Brain MRI

Device: MRI

patients after moderate-severe TBI

Experimental group

Treatment:

Device: Brain MRI

Device: MRI