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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03998930 -
Evaluation of Consciousness by Brain-computer Interface in Severely Brain Damaged Patients
|
N/A | |
| Recruiting |
NCT05636020 -
Intervention to Change Affect Recognition and Empathy
|
N/A | |
| Completed |
NCT04306601 -
Low-Intensity Focused Ultrasound on Individuals With Disorder of Consciousness of Traumatic Brain Injury
|
N/A |