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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by Bayside Health.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163878
First Posted: September 14, 2005
Last Update Posted: October 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Victorian Trauma Foundation
Information provided by:
Bayside Health
  Purpose
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).

Condition Intervention Phase
Traumatic Brain Injury Procedure: Sensory Stimulation Device: Sesnory Modality Assessment and Rehabilitation Technique Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomised Control Trial to Determine the Effectiveness of Sensory Stimulation Program in Reducing the Length of Time Spent by Severely Brain Injured Patients in a Vegetative State in the Acute Hospital Environment

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups

Secondary Outcome Measures:
  • Fucntional status at six months, assessed using the modified Barthel

Study Start Date: November 2004
Estimated Study Completion Date: December 2006
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 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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163878


Contacts
Contact: Jacqui M Morarty, Occupational Therapist 61 (0)3 92763526 j.morarty@alfred.org.au

Locations
Australia, Victoria
The Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Jacqui M Morarty, Occupational Therapist    61 3 9276 3526    j.morarty@alfred.org.au   
Principal Investigator: Jacqui M Morarty, Occupational Therapist         
The Alfred Hosptial Recruiting
Melbourne, Victoria, Australia, 3181
Contact: Jacqui M Morarty, Occupational Therapist    6103 9276 3526    j.morarty@alfred.org.au   
Principal Investigator: Jacqui M Morarty, Occupational Therapist         
Sponsors and Collaborators
Bayside Health
Victorian Trauma Foundation
Investigators
Principal Investigator: Jacqui M Morarty, Occupational Therapist Bayside Health
  More Information

ClinicalTrials.gov Identifier: NCT00163878     History of Changes
Other Study ID Numbers: 4468
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: October 4, 2006
Last Verified: August 2005

Keywords provided by Bayside Health:
Sensory Stimulation Programs

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Persistent Vegetative State
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms