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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00163878
• Other study ID #: 4468
• Status: Recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: October 3, 2006
• Start date: November 2004
• Est. completion date: December 2006

Study information

• Verified date: August 2005
• Source: Bayside Health
• Contact: Jacqui M Morarty, Occupational Therapist
• Phone: 61 (0)3 92763526
• Email: j.morarty[@]alfred.org.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Traumatic Brain Injury

Intervention

Procedure:
• Sensory Stimulation

Device:
• Sesnory Modality Assessment and Rehabilitation Technique

Locations

Country	Name	City	State
Australia	The Alfred Hosptial	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	Victorian Trauma Foundation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups
Secondary	Fucntional status at six months, assessed using the modified Barthel