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

Traumatic Brain Injury With Prolonged Loss of Consciousness Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02589223
• Other study ID #: MSS2015
• Status: Terminated
• Phase: N/A
• Start date: February 16, 2017
• Est. completion date: September 22, 2017

Study information

• Verified date: July 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 22, 2017
• Est. primary completion date: September 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury With Prolonged Loss of Consciousness
• Unconsciousness
• Wounds and Injuries

Intervention

Other:
• Multisensory Stimulation
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
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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	Enrollment rates		To be collected during the patient enrollment process (study duration approximately 1 year).
Secondary	Barriers to enrollment		To be collected during the patient enrollment process (study duration approximately 1 year).
Secondary	Duration of each intervention session (minutes)		To be collected at the end each intervention session throughout the 4 week intervention period.
Secondary	Pre/post-intervention heart rate (beats/minute)		To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
Secondary	Sp02 reading (percentage)		To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
Secondary	Respiratory Rate (breaths/minute)		To be collected at the beginning and end of each intervention session throughout the 4 week intervention period.
Secondary	ICU Mobility Scale Score		Daily scores are recorded and eventually averaged over 4 week intervention period.
Secondary	Number of intervention sessions (control or multisensory stimulation) per patient over 4 week period		To be collected at the end of 4 week intervention period.
Secondary	Barriers to intervention		To be collected (as applicable) at the end of each intervention session throughout the 4 week intervention period.
Secondary	Date of patient transfer from TNICU to ward		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).
Secondary	Patient length of stay (days)		To be collected when patient is discharged/transferred from hospital. (which will be at any time, up to 6 months after study enrollment).
Secondary	Discharge Destination		To be recorded when patient is discharged/transferred from hospital (which will be at any time, up to 6 months after study enrollment).