Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State - Full Text View

Sponsors and Collaborators:	Bayside Health Victorian Trauma Foundation
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00163878

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation Traumatic Brain Injury

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163878

Contacts

Contact: Jacqui M Morarty, Occupational Therapist

61 (0)3 92763526

j.morarty@alfred.org.au

Locations

Australia, Victoria
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
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

Sponsors and Collaborators

Bayside Health

Victorian Trauma Foundation

Investigators

Principal Investigator:

Jacqui M Morarty, Occupational Therapist

Bayside Health

More Information

No publications provided

Study ID Numbers:	4468
Study First Received:	September 12, 2005
Last Updated:	October 3, 2006
ClinicalTrials.gov Identifier:	NCT00163878 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:

Sensory Stimulation Programs

Study placed in the following topic categories:

Persistent Vegetative State
Craniocerebral Trauma
Unconsciousness
Brain Damage, Chronic
Consciousness Disorders
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin

Trauma, Nervous System
Brain Diseases
Coma
Signs and Symptoms
Neurologic Manifestations
Brain Injuries
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Persistent Vegetative State
Craniocerebral Trauma
Unconsciousness
Nervous System Diseases
Brain Damage, Chronic
Consciousness Disorders
Wounds and Injuries
Central Nervous System Diseases

Disorders of Environmental Origin
Trauma, Nervous System
Brain Diseases
Signs and Symptoms
Neurologic Manifestations
Brain Injuries
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on September 11, 2009