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

NCT02589223 | Terminated

• 1 other identifier: MSS2015
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury With Prolonged Loss of Consciousness

Keywords

multisensory stimulation

Outcome Measures

Primary Outcomes (1)

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

  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

  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

  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

  To be collected during the patient enrollment process (study duration approximately 1 year).

• Barriers to enrollment

  To be collected during the patient enrollment process (study duration approximately 1 year).

• Duration of each intervention session (minutes)

  To be collected at the end each intervention session throughout the 4 week intervention period.

Study Arms (2)

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).

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.

Other: Control

Interventions

Multisensory Stimulation OTHER

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).

Multisensory Stimulation Group

Control OTHER

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.

Control Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Study Officials

• Catherine A St. Louis, BSc, MHSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 28, 2015
• Study Start: February 16, 2017
• Primary Completion: September 22, 2017
• Study Completion: September 22, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)