Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State

Phase

Condition

Traumatic Brain Injury

Neurologic Disorders

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00163878

4468

Ages 18-65
All Genders

Study 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 experimental group would receive, in addition to their normal occuaptional therapy, sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique (SMART).

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

Study Design

November 01, 2004

December 31, 2006

Study 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 experimental group would receive, in addition to their normal occupational therapy, sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique (SMART).

The SMART is both an assessment and treatment too. Patients in both groups will have baseline assessments conducted using the SMART, with further assessments conducted every ten days for thrity days. The SMART is designed to provide quantitative data in the assessment of the patients cognitive function and potential awareness. It is a five point hierarchical scale from level 1 ( no response) to level 5 (discriminating).

Connect with a study center

The Alfred Hosptial
Melbourne, Victoria 3181
Australia
Active - Recruiting
The Royal Melbourne Hospital
Melbourne, Victoria 3050
Australia
Active - Recruiting

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