Traumatic Brain Injury With Prolonged Loss of ConsciousnessNCT02589223
A Trial to Determine the Feasibility and Effectiveness of Early Multisensory Stimulation Intervention in Patients in the Trauma-Neurosurgical Intensive Care Unit (TNICU) Following Severe Acquired Brain Injury
A study testing Multisensory Stimulation in people with Traumatic Brain Injury With Prolonged Loss of Consciousness, run by Unity Health Toronto at 1 site in Canada.
Trial summary
St. Michael's Hospital (SMH) provides service to individuals with some of the most severe brain injuries and intensive care needs in Canada. These patients often require prolonged intensive care admissions, lengthy hospital stays, involvement of many health professionals, and long-term support for ongoing care… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury With Prolonged Loss of Consciousness
- What is being tested?
- Multisensory Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 16 Feb 2017to 22 Sep 2017
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 2 weeks post injury, no more than 8 weeks post injury
- Glasgow Coma Scale score of less than or equal to 9, or motor component score of 5 or less if patient intubated
- No previous brain injury
- No chronic/progressive neurological illness
- No intracranial pressure monitor
- No more than1 pre-existing sensory impairment (e.g. deafness, blindness)
Show all 9Show fewer
- Functional level of English for patient and Substitute Decision Maker (i.e. conversational English, work/education in English, completion of English as a Second Language course, etc.)
- Deemed medically appropriate as per Nurse Practitioner/MD (e.g. no active seizures, no sedation, haemodynamically stable, etc.)
- Exclusion Criteria: Patients who do not meet inclusion criteria above.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial to Determine the Feasibility and Effectiveness of Early Multisensory Stimulation Intervention in Patients in the Trauma-Neurosurgical Intensive Care Unit (TNICU) Following Severe Acquired Brain Injury
St. Michael's Hospital (SMH) provides service to individuals with some of the most severe brain injuries and intensive care needs in Canada. These patients often require prolonged intensive care admissions, lengthy hospital stays, involvement of many health professionals, and long-term support for ongoing care requirements. Many hospitals face resource limitations, specifically involving the health disciplines and their ability to provide frequent intervention.
It has been proposed that multisensory stimulation (i.e. exposing the patient to various sights, sounds, smells, etc.) in the early stages of brain injury recovery may result in improved responsiveness/cognitive function.
Previous research has indicated a potential benefit for early multisensory stimulation intervention for patients with severe brain injury. However there is still not enough conclusive evidence to confirm whether the intervention is truly effective. The investigators are proposing a pilot randomized controlled study (placebo-controlled, double-blinded) to determine the feasibility and examine the effectiveness of early multisensory stimulation with patients following severe brain injury who remain in a coma, vegetative state, or minimally conscious state. Eligible patients will be randomized to a control group (standard care + family/caregiver education) or an intervention group (standard care + family/caregiver education + early sensory intervention). Data regarding number of patients enrolled, amount of intervention completed, percentage of outcome data collected, patient's level of responsiveness and cognitive function will be collected before and after the intervention period, using several outcome measures. The investigators hope to determine the feasibility of conducting this type of study within this clinical setting and the effectiveness of multisensory stimulation with this patient population.
- Being tested
- Multisensory Stimulation, Control
- Keywords
- multisensory stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory StimulationOther
Subjects assigned to the multisensory stimulation group will receive the multisensory stimulation protocol designed for the study, which will include a variety of techniques designed to awaken the individual. Stimulus provided may include: visual activities (i.e. presenting the individual with objects/pictures to look at), auditory information (i.e. playing music or speaking), tactile stimuli (i.e. touching the individual with materials of different textures), taste and smell stimuli (i.e. offering items for the individual to taste or smell).
ControlOther
Intervention sessions will occur 3 times per week, for approximately 30 minutes per session for a total of 4 weeks. During each session, subjects will be played a pre-recorded reading of complex material for 30 minutes, in order to assist with control/blinding.
| Study group | Role | What they receive |
|---|---|---|
| Multisensory Stimulation Group | Active comparator | Intervention sessions will occur 3 times per week, for approximately 30 minutes per session for a total of 4 weeks. Subjects assigned to the multisensory stimulation group will receive the multisensory stimulation protocol designed for the study, which will include a variety of techniques designed to awaken the individual. Stimulus provided may include: visual activities (i.e. presenting the individual with objects/pictures to look at), auditory information (i.e. playing music or speaking), tactile stimuli (i.e. touching the individual with materials of different textures), taste and smell stimuli (i.e. offering items for the individual to taste or smell). Receives: Other: Multisensory Stimulation |
| Control Group | Placebo comparator | Intervention sessions will occur 3 times per week, for approximately 30 minutes per session for a total of 4 weeks. During each session, subjects will be played a pre-recorded reading of complex material for 30 minutes, in order to assist with control/blinding. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Neurosensory Stimulation Profile - to assess change in alertness and cognitive functioning
Measured: To be administered pre intervention (once consent obtained and prior to intervention - to obtain baseline data) and post intervention (after 4 week intervention period to determine change in alertness/cognitive functioning post intervention).
Secondary outcomes (14)
Ranchos Los Amigos Levels of Cognitive Functioning Scale
Measured: To be administered pre intervention (once consent obtained and prior to intervention - to obtain baseline data) and post intervention (after 4 week intervention period to determine change in alertness/cognitive functioning post intervention).
Glasgow Coma Scale
Measured: To be administered pre intervention (once consent obtained and prior to intervention - to obtain baseline data) and post intervention (after 4 week intervention period to determine change in alertness/responsiveness post intervention).
Enrollment rates
Measured: To be collected during the patient enrollment process (study duration approximately 1 year).
Barriers to enrollment
Measured: To be collected during the patient enrollment process (study duration approximately 1 year).
Duration of each intervention session (minutes)
Measured: To be collected at the end each intervention session throughout the 4 week intervention period.
Pre/post-intervention heart rate (beats/minute)
Measured: To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
Sp02 reading (percentage)
Measured: To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
Respiratory Rate (breaths/minute)
Measured: To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
ICU Mobility Scale Score
Measured: Daily scores are recorded and eventually averaged over 4 week intervention period.
Number of intervention sessions (control or multisensory stimulation) per patient over 4 week period
Measured: To be collected at the end of 4 week intervention period.
Barriers to intervention
Measured: To be collected (as applicable) at the end of each intervention session throughout the 4 week intervention period.
Date of patient transfer from TNICU to ward
Measured: To be collected when patient transferred from TNICU to ward (which may be at any time throughout study period, up to 6 months after study enrollment).
Patient length of stay (days)
Measured: To be collected when patient is discharged/transferred from hospital. (which will be at any time, up to 6 months after study enrollment).
Discharge Destination
Measured: To be recorded when patient is discharged/transferred from hospital (which will be at any time, up to 6 months after study enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start16 Feb 2017
- Primary completion22 Sep 2017
- Study completion22 Sep 2017
Why it stopped: Our enrollment numbers were low - very few eligible study subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury With Prolonged Loss of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine A St. Louis, BSc, MHSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589223
- Sponsor's protocol ID
- MSS2015
- Status last verified
- Jul 2018
- First submitted
- 21 Oct 2015
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial to Determine the Feasibility and Effectiveness of Early Multisensory Stimulation Intervention in Patients in the Trauma-Neurosurgical Intensive Care Unit (TNICU) Following Severe Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT02589223
- Acronym / sponsor ID
- MSS2015
- Keywords
- multisensory stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Our enrollment numbers were low - very few eligible study subjects.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 22 Sep 2017 (actual)
- Study completion
- 22 Sep 2017 (actual)
- First posted
- 28 Oct 2015 (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.
St. Michael's Hospital (SMH) provides service to individuals with some of the most severe brain injuries and intensive care needs in Canada. These patients often require prolonged intensive care admissions, lengthy hospital stays, involvement of many health professionals, and long-term support for ongoing care requirements. Many hospitals face resource limitations, specifically involving the health disciplines and their ability to provide frequent intervention.
It has been proposed that multisensory stimulation (i.e. exposing the patient to various sights, sounds, smells, etc.) in the early stages of brain injury recovery may result in improved responsiveness/cognitive function.
Previous research has indicated a potential benefit for early multisensory stimulation intervention for patients with severe brain injury. However there is still not enough conclusive evidence to confirm whether the intervention is truly effective. The investigators are proposing a pilot randomized controlled study (placebo-controlled, double-blinded) to determine the feasibility and examine the effectiveness of early multisensory stimulation with patients following severe brain injury who remain in a coma, vegetative state, or minimally conscious state. Eligible patients will be randomized to a control group (standard care + family/caregiver education) or an intervention group (standard care + family/caregiver education + early sensory intervention). Data regarding number of patients enrolled, amount of intervention completed, percentage of outcome data collected, patient's level of responsiveness and cognitive function will be collected before and after the intervention period, using several outcome measures. The investigators hope to determine the feasibility of conducting this type of study within this clinical setting and the effectiveness of multisensory stimulation with this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisensory Stimulation Group | Active comparator | Other: Multisensory StimulationIntervention sessions will occur 3 times per week, for approximately 30 minutes per session for a total of 4 weeks. Subjects assigned to the multisensory stimulation group will receive the multisensory stimulation protocol designed for the study, which will include a variety of techniques designed to awaken the individual. Stimulus provided may include: visual activities (i.e. presenting the individual with objects/pictures to look at), auditory information (i.e. playing music or speaking), tactile stimuli (i.e. touching the individual with materials of different textures), taste and smell stimuli (i.e. offering items for the individual to taste or smell). |
| Control Group | Placebo comparator | Other: ControlIntervention sessions will occur 3 times per week, for approximately 30 minutes per session for a total of 4 weeks. During each session, subjects will be played a pre-recorded reading of complex material for 30 minutes, in order to assist with control/blinding. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- At least 2 weeks post injury, no more than 8 weeks post injury
- Glasgow Coma Scale score of less than or equal to 9, or motor component score of 5 or less if patient intubated
- No previous brain injury
- No chronic/progressive neurological illness
- No intracranial pressure monitor
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Multisensory StimulationSubjects assigned to the multisensory stimulation group will receive the multisensory stimulation protocol designed for the study, which will include a variety of techniques designed to awaken the individual. Stimulus provided may include: visual activities (i.e. presenting the individual with objects/pictures to look at), auditory information (i.e. playing music or speaking), tactile stimuli (i.e. touching the individual with materials of different textures), taste and smell stimuli (i.e. offering items for the individual to taste or smell). | Other | Multisensory Stimulation Group |
| ControlIntervention sessions will occur 3 times per week, for approximately 30 minutes per session for a total of 4 weeks. During each session, subjects will be played a pre-recorded reading of complex material for 30 minutes, in order to assist with control/blinding. | Other | Control Group |
Primary outcome
Western Neurosensory Stimulation Profile - to assess change in alertness and cognitive functioning
Time frame: To be administered pre intervention (once consent obtained and prior to intervention - to obtain baseline data) and post intervention (after 4 week intervention period to determine change in alertness/cognitive functioning post intervention).
14 secondary outcomes
Ranchos Los Amigos Levels of Cognitive Functioning Scale
Time frame: To be administered pre intervention (once consent obtained and prior to intervention - to obtain baseline data) and post intervention (after 4 week intervention period to determine change in alertness/cognitive functioning post intervention).
Glasgow Coma Scale
Time frame: To be administered pre intervention (once consent obtained and prior to intervention - to obtain baseline data) and post intervention (after 4 week intervention period to determine change in alertness/responsiveness post intervention).
Enrollment rates
Time frame: To be collected during the patient enrollment process (study duration approximately 1 year).
Barriers to enrollment
Time frame: To be collected during the patient enrollment process (study duration approximately 1 year).
Duration of each intervention session (minutes)
Time frame: To be collected at the end each intervention session throughout the 4 week intervention period.
Pre/post-intervention heart rate (beats/minute)
Time frame: To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
Sp02 reading (percentage)
Time frame: To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
Respiratory Rate (breaths/minute)
Time frame: To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
ICU Mobility Scale Score
Time frame: Daily scores are recorded and eventually averaged over 4 week intervention period.
Number of intervention sessions (control or multisensory stimulation) per patient over 4 week period
Time frame: To be collected at the end of 4 week intervention period.
Barriers to intervention
Time frame: To be collected (as applicable) at the end of each intervention session throughout the 4 week intervention period.
Date of patient transfer from TNICU to ward
Time frame: To be collected when patient transferred from TNICU to ward (which may be at any time throughout study period, up to 6 months after study enrollment).
Patient length of stay (days)
Time frame: To be collected when patient is discharged/transferred from hospital. (which will be at any time, up to 6 months after study enrollment).
Discharge Destination
Time frame: To be recorded when patient is discharged/transferred from hospital (which will be at any time, up to 6 months after study enrollment).
Results and safety
The study was stopped early (reason given: Our enrollment numbers were low - very few eligible study subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Catherine A St. Louis, BSc, MHSc principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory Stimulation in people with Traumatic Brain Injury With Prolonged Loss of Consciousness, run by Unity Health Toronto at 1 site in Canada.
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 9 inclusion and 0 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: stopped early, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Our enrollment numbers were low - very few eligible study subjects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Neurosensory Stimulation Profile - to assess change in alertness and cognitive functioning (time frame: To be administered pre intervention (once consent obtained and prior to intervention - to obtain baseline data) and post intervention (after 4 week intervention period to determine change in alertness/cognitive functioning post intervention).). 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 24 Jul 2018.