Traumatic Brain Injury Clinical Trial
Official title:
Can Neural Adaptation After Severe Brain Injury be Facilitated?
The purpose of the study is to determine whether familiar vocal stimulation, provided during
coma recovery, improves outcomes for persons who are unconscious after severe TBI. The
primary hypothesis is that unconscious persons who receive standard rehabilitation (SR) plus
a high-dose of Familiar Voice stimulation (FVs) compared to unconscious persons who receive
SR plus a sham stimulation (Sham Group) will demonstrate:
1. Significantly more neurobehavioral functioning post-intervention compared to
pre-intervention.
2. Using Functional Magnetic Resonance Imaging (fMRI), significantly higher average
measures of volumetric activity in the whole brain, middle temporal gyrus bilaterally,
primary auditory area, bilateral pre-frontal cortex, hippocampus and/or the cerebellum
post-intervention compared to pre-intervention.
Medical advances have improved the odds of surviving a severe traumatic brain injury (TBI)
thereby increasing demands for rehabilitation. Medical rehabilitation management during coma
recovery, however, has been hampered by a paucity of rigorous clinical trials examining
rehabilitation effectiveness. This randomized clinical trial addresses this knowledge gap.
The purpose of the study is to determine whether a high dose of familiar vocal stimulation
(FVs) improves outcomes for persons who are unconscious after severe TBI. The research
objectives are to:
1. Determine whether neural responses elicited with FVs improve neurobehavioral outcomes
and/or elicit activations in expected regions.
2. Examine the relationship between neurobehavioral and neurophysiological responses to
high doses of FVs during coma recovery.
There are two study cohorts and each group receives standard rehabilitation. The experimental
group will be exposed daily to 40 minutes of FVs for 6 weeks. The Sham Group (Control Group
2) will receive 40 minutes of sham treatment, or silence, daily for 6 weeks.
The 40 minutes of FVs treatment will be provided in four 10 minute sessions. Each FV session
will start with the subject hearing a familiar voice call the 'Subject's Own Name' aloud and
then that same voice re-telling a memory or an event familiar to the subject. The person
re-telling the event will be a person who experienced the event with the subject and who
interacted with the subject on a daily basis for at least 1 year prior to injury.
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