Status:
UNKNOWN
Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
Victorian Trauma Foundation
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state. The experi...
Detailed Description
A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state. The experi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- admitted with severe brain injury
- GCS of 9 or less. A GCS score of 9 or less is indicative of a severe brain injury
- medically stable, as documented by medical staff
- age 18 to 65 years
- controlled intracranial pressure no sedation
- no previous brain injury
- Exclusion Criteria
- patient declared brain dead
- next of kin withdraws patient from the study
- withdrawal of consent by patient on waking
- raised uncontrolled intracranial pressure, following discussions with treating medical team
- patient enrolled in DECRA or RSI Trials
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00163878
Start Date
November 1 2004
End Date
December 1 2006
Last Update
October 4 2006
Active Locations (2)
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1
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
2
The Alfred Hosptial
Melbourne, Victoria, Australia, 3181