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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

Primary Purpose

Traumatic Brain Injury With Prolonged Loss of Consciousness

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multisensory Stimulation
Control
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury With Prolonged Loss of Consciousness focused on measuring multisensory stimulation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)
  • 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.

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Multisensory Stimulation Group

Control Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Western Neurosensory Stimulation Profile - to assess change in alertness and cognitive functioning

Secondary Outcome Measures

Ranchos Los Amigos Levels of Cognitive Functioning Scale
Glasgow Coma Scale
Enrollment rates
Barriers to enrollment
Duration of each intervention session (minutes)
Pre/post-intervention heart rate (beats/minute)
Sp02 reading (percentage)
Respiratory Rate (breaths/minute)
ICU Mobility Scale Score
Number of intervention sessions (control or multisensory stimulation) per patient over 4 week period
Barriers to intervention
Date of patient transfer from TNICU to ward
Patient length of stay (days)
Discharge Destination

Full Information

First Posted
October 21, 2015
Last Updated
July 20, 2018
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02589223
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Our enrollment numbers were low - very few eligible study subjects.
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
September 22, 2017 (Actual)
Study Completion Date
September 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury With Prolonged Loss of Consciousness
Keywords
multisensory stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multisensory Stimulation Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multisensory Stimulation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Secondary Outcome Measure Information:
Title
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).
Title
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).
Title
Enrollment rates
Time Frame
To be collected during the patient enrollment process (study duration approximately 1 year).
Title
Barriers to enrollment
Time Frame
To be collected during the patient enrollment process (study duration approximately 1 year).
Title
Duration of each intervention session (minutes)
Time Frame
To be collected at the end each intervention session throughout the 4 week intervention period.
Title
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.
Title
Sp02 reading (percentage)
Time Frame
To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
Title
Respiratory Rate (breaths/minute)
Time Frame
To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
Title
ICU Mobility Scale Score
Time Frame
Daily scores are recorded and eventually averaged over 4 week intervention period.
Title
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.
Title
Barriers to intervention
Time Frame
To be collected (as applicable) at the end of each intervention session throughout the 4 week intervention period.
Title
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).
Title
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).
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine A St. Louis, BSc, MHSc
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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