Traumatic Brain InjuryPhase 4NCT00163878
Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State
A Phase 4 study testing Sensory Stimulation and Sesnory Modality Assessment and Rehabilitation Technique in people with Traumatic Brain Injury, run by Bayside Health at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Sensory Stimulation and Sesnory Modality Assessment and Rehabilitation Technique
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesAustralia
- Study dates
- Nov 2004to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
Jacqui M Morarty, Occupational Therapist, 61 3 9276 3526, j.morarty@alfred.org.au
Jacqui M Morarty, Occupational Therapist
- Recruiting
The Alfred Hosptial
Melbourne, Victoria, 3181
Jacqui M Morarty, Occupational Therapist, 6103 9276 3526, j.morarty@alfred.org.au
Jacqui M Morarty, Occupational Therapist
About this study
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
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).
Read the 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).
- Conditions
- Traumatic Brain Injury
- Being tested
- Sensory Stimulation, Sesnory Modality Assessment and Rehabilitation Technique
- Keywords
- Sensory Stimulation Programs
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory StimulationProcedure or surgery
Sesnory Modality Assessment and Rehabilitation TechniqueDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups
Secondary outcomes (1)
Fucntional status at six months, assessed using the modified Barthel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startNov 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Victorian Trauma Foundation
- Investigators
- Jacqui M Morarty, Occupational Therapist, Principal investigator, Bayside Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163878
- Sponsor's protocol ID
- 4468
- Status last verified
- Aug 2005
- First submitted
- 12 Sep 2005
- Last updated
- 4 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00163878
- Acronym / sponsor ID
- 4468
- Conditions
- Traumatic Brain Injury
- Keywords
- Sensory Stimulation Programs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Victorian Trauma Foundation
- Study start
- Nov 2004
- Study completion
- Dec 2006
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Stimulation | Procedure or surgery | – |
| Sesnory Modality Assessment and Rehabilitation Technique | Device | – |
Primary outcome
Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups
1 secondary outcome
Fucntional status at six months, assessed using the modified Barthel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqui M Morarty, Occupational Therapist principal investigator
Bayside Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sensory Stimulation and Sesnory Modality Assessment and Rehabilitation Technique in people with Traumatic Brain Injury, run by Bayside Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacqui M Morarty, Occupational Therapist (61 (0)3 92763526, j.morarty@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2006.