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

Phase 4

• Conditions: Traumatic Brain Injury

• Registration Number: NCT00163878
• Lead Sponsor: Bayside Health

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).

Study Timeline

• Study Start: 2004-11
• Status Verified: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Last Update Submitted: 2006-10-03
• Last Update Posted: 2006-10-04
• Study Completion: 2006-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Fucntional status at six months, assessed using the modified Barthel

Trial Locations

Locations (2)

The Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

The Alfred Hosptial; 🇦🇺 Melbourne, Victoria, Australia