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

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

Sensory Stimulation

Sesnory Modality Assessment and Rehabilitation Technique

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Sensory Stimulation Programs

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Royal Melbourne HospitalRecruiting
The Alfred HosptialRecruiting

Outcomes

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

Full Information

NCT ID

NCT00163878

First Posted

September 12, 2005

Last Updated

October 3, 2006

Sponsor

Bayside Health

Collaborators

Victorian Trauma Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00163878

Brief Title

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

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Unknown status

Study Start Date

November 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Bayside Health

Collaborators

Victorian Trauma Foundation

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

Sensory Stimulation Programs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Sensory Stimulation

Intervention Type

Device

Intervention Name(s)

Sesnory Modality Assessment and Rehabilitation Technique

Primary Outcome Measure Information:

Title

Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups

Secondary Outcome Measure Information:

Title

Fucntional status at six months, assessed using the modified Barthel

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jacqui M Morarty, Occupational Therapist

Phone

61 (0)3 92763526

Email

j.morarty@alfred.org.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacqui M Morarty, Occupational Therapist

Organizational Affiliation

Bayside Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Royal Melbourne Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacqui M Morarty, Occupational Therapist

Phone

61 3 9276 3526

Email

j.morarty@alfred.org.au

First Name & Middle Initial & Last Name & Degree

Jacqui M Morarty, Occupational Therapist

Facility Name

The Alfred Hosptial

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacqui M Morarty, Occupational Therapist

Phone

6103 9276 3526

Email

j.morarty@alfred.org.au

First Name & Middle Initial & Last Name & Degree

Jacqui M Morarty, Occupational Therapist

Traumatic Brain Injury

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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