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

Last updated: October 3, 2006
Sponsor: Bayside Health
Overall Status: Trial Status Unknown

Phase

4

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

Study Start date:
November 01, 2004
Estimated Completion Date:
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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