Clinical trial NCT00163878: Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Traumatic Brain Injury
Keywords: Sensory Stimulation Programs
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Victorian Trauma Foundation
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups
Secondary outcomes:
measure: Fucntional status at six months, assessed using the modified Barthel
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hosptial
state: Victoria
Study officials:
affiliation: Bayside Health
name: Jacqui M Morarty, Occupational Therapist
role: PRINCIPAL_INVESTIGATOR
References: