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

October 3, 2006 updated by: Bayside Health

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital
        • Contact:
        • Principal Investigator:
          • Jacqui M Morarty, Occupational Therapist
      • Melbourne, Victoria, Australia, 3181
        • Recruiting
        • The Alfred Hosptial
        • Principal Investigator:
          • Jacqui M Morarty, Occupational Therapist
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Fucntional status at six months, assessed using the modified Barthel

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Collaborators

Victorian Trauma Foundation

Investigators

  • Principal Investigator: Jacqui M Morarty, Occupational Therapist, Bayside Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

October 4, 2006

Last Update Submitted That Met QC Criteria

October 3, 2006

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4468

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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