Background: Traumatic Brain Injury (TBI) is a medical and surgical epidemic affecting at
least 1.7 million individuals yearly in the United States. Functional outcomes after TBI
can show improvement or deterioration up to two decades after injury, and rates of
all-cause mortality remain elevated for many years. Cognitive impairments are among the
most disabling of post-TBI symptoms and typically contribute more to persisting
disability than physical impairment. Following TBI, deficits are consistently
demonstrated in the domains of attention, working memory and executive functioning. To
date, there are some potential interventions for motor/functional recovery but there is
no treatment for cognitive dysfunction which is more disabling. Although brain
stimulation techniques appear promising as treatments to improve neuropsychiatric
conditions and functional deficits, most noninvasive brain stimu¬lation interventions
have been nontargeted and focused on the chronic phase of recovery after TBI. In the
acute stages, there is limited available evidence of the efficacy and safety of brain
stimulation to improve outcomes. The stimulation during chronic phase is applied either
in isolation or before cognitive training. TBI thus underscores a major unaddressed
challenge: the lack of time sensitive cognitive rehabilitation therapy post injury. Thus,
there is an urgent need to develop rehabilitation paradigms in the early phases of injury
for cognitive recovery and prevention of long-term cognitive impairments.
Hypothesis/Objective(s): This study is based on the hypothesis that early intervention
with anodal transcranial electrical stimulation (A-tES) during the acute and sub-acute
phases of TBI will enhance cognitive recovery over a similar intervention used only in
the sub-acute phase. The objective of this study is to determine neural biomarkers of
cognitive functional recovery in TBI and to investigate the neuromodulatory effects of
early A-tES on cognitive functions in the sub-acute/chronic phases of TBI.
Specific Aims: (1) To determine neural correlates of cognitive recovery from injury over
the acute to sub-acute/chronic phase in TBI, (2) To determine effects of time from injury
when A-tES was administered on cognitive performance and associated EEG rhythms in TBI.
Study Design: The investigators will conduct a pilot clinical trial over a 3-year period
in which we aim to recruit 60 patients with moderate to severe isolated TBI at the
University of Cincinnati Medical Center (UCMC). All recruited participants will be
administered a Brief test of adult cognition (BTACT) at bedside during the acute phase.
They will perform 2 cognitive tasks on a laptop computer while their EEGs are being
recorded. 50% of recruited patients selected randomly during the acute phase will receive
active A-tES to their left dorsolateral prefrontal cortex (dlPFC) for 15 minutes each
during the performance of cognitive tasks while the rest will receive sham stimulation.
All participants will be followed for 6 months. When they return for their typical
3-month follow-up, we will perform another session with BTACT, EEG and cognitive tasks.
During this visit all participants will receive active A-tES to their left dlPFC while
performing cognitive tasks. In their last visit at 6 months post injury, all participants
will be administered BTACT and cognitive tasks with EEG recordings but no intervention.
They will also complete a quality of life (QOL) questionnaire designed through
involvement of CBPR during their follow-up visits. For Aim 1, the investigators will
determine if there are significant temporal correlations between neural oscillations
recorded via EEG during the performance of cognitive tasks and injury phase. For Aim 2,
the investigators will use a double-blind, randomized, sham-controlled, parallel study
design to assess effects of early A-tES on improving performance on computer tasks,
clinical test ratings and QOL measures during the 6-month post injury follow-up compared
to A-tES delivered during the 3-month follow up visit.