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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Procedure: Sensory Stimulation
* Device: Sesnory Modality Assessment and Rehabilitation Technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Sensory Stimulation|nan|
|Device: Sesnory Modality Assessment and Rehabilitation Technique|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Fucntional status at six months, assessed using the modified Barthel |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensory Stimulation Programs