Improving New Learning and Memory in Traumatic Brain Injury

Impairments in higher level cognitive processing, such as new learning and memory, are among
the most common deficits in individuals with Traumatic Brain Injury (TBI) and such deficits
have been shown to exert significant negative impact on multiple aspects of everyday life,
including occupational and social functioning. Despite these findings, few studies have
attempted to remediate these cognitive deficits in order to improve the everyday functioning
of individuals with TBI

Therefore, we will conduct a double-blind, placebo-controlled, randomized clinical trial,
applying a memory rehabilitation technique to a large sample of TBI participants. This
protocol has been well-validated with other neurological populations and preliminary
evidence in support of its use in MS now exists. Individuals with TBI, with documented
impairment in memory and new learning, will be randomly assigned to either a memory
retraining group or a placebo control group. Outcome will be measured through two
mechanisms: (1) a traditional neuropsychological (NP) battery and (2) an assessment of
global functioning (AGF) examining the impact of the treatment on daily activities. Both
groups will undergo baseline, immediate follow-up, and long-term follow-up assessments
consisting of a traditional NP evaluation, which examines objective performance on
well-validated measures of cognitive function, and an AGF, which includes self-report
measures of memory abilities, self-efficacy, quality of life, and occupational functioning.
In this way, we will be able to objectively evaluate the presence or absence of changes in
memory performance through a NP assessment, while also evaluating the impact of this
treatment protocol on an individual's everyday life through the AGF. While most studies
evaluating the efficacy of cognitive retraining usually employ a pre-training and
post-training evaluation, such evaluations have been criticized for their lack of ecological
validity. The present design allows the assessment of the efficacy of this particular memory
retraining technique within an TBI population using traditional measures, as well as the
assessment of the impact that such a rehabilitation technique has on everyday life. In
addition, we will include a 6-month follow-up assessment to measure the long-term impact of
this treatment on objective cognitive functioning, through a NP assessment, and everyday
life, through an AGF. Finally, half of the participants in the experimental group will
participate in monthly "booster sessions" following the completion of treatment and we will
evaluate the impact of these sessions on the maintenance of treatment effects over time. A
subset of the sample will also complete pre and post neuroimaging to evaluate changes in
cerebral activation.

The documentation of the efficacy of memory retraining in TBI, particularly on everyday
functioning, could have a significant impact on symptom management and quality of life in
the lives of persons. As such, specific aims of the current research protocol are as
follows.

Aim 1. This study will objectively evaluate the clinical utility of a memory retraining
protocol to improve performance on objective tests of new learning and memory in a large
sample of individuals with TBI with documented deficits in this area.

Aim 2. We will increase the generalizability and real life application of assessment
techniques by assessing outcome following cognitive retraining with more global measures of
everyday life. An objective measure of everyday functioning will be included, as well as
numerous subjective measures of everyday functioning, which will be gathered via established
self-report instruments, as well as ratings by a significant other.

Aim 3: This study will evaluate the long-term efficacy of this memory retraining protocol
through the inclusion of a 6-month follow-up assessment. Many cognitive remediation studies
in the literature examine the efficacy of the treatment immediately following program
completion. However, given the time, expense, and labor involved in such intensive
treatment, it is important to demonstrate the long-term efficacy of such a program. The
current study therefore goes beyond the typical protocol length to evaluate the long-term
impact such treatment will have on objective testing and on an individual's daily life.

Aim 4: We will examine the need for and impact of "booster sessions" following the
completion of treatment. "Booster sessions" have been shown to be efficacious in maximizing
the long term benefit of cognitive retraining in research with other populations. However,
the utility of booster sessions in a TBI population has never been investigated.

Inclusion Criteria:

- English as primary language

- Diagnosis of TBI, at least one year post-injury

Exclusion Criteria:

- ages less than 18 or greater than 59

- previous head injury, stroke, seizures, or any other significant neurological history

- Medications: persons on steroids, benzodiazepines, and/or neuroleptics will not be
included

- Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia,
Bipolar Disorder I or II will be excluded from the study

- Significant history of drug or alcohol abuse

- Poor Visual Acuity (corrected vision in worse eye < 20/60), diplopia, or nystagmus

- Inability to understand directions and following one, two, and three step commands

- Intact New Learning and Memory: Only individuals that show impaired performance on a
memory test will be included in the study