Improving New Learning and Memory in Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The current study is a double-blind, placebo-control randomized clinical trial examining the
      efficacy of memory retraining in Traumatic Brain Injury (TBI). Impairment in higher level
      cognitive processing, such as new learning and memory, is one of the most common deficits in
      individuals with 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 treat these cognitive deficits in order to
      improve the everyday functioning of individuals with TBI. The current proposal will evaluate
      (a)the efficacy of this treatment protocol within a TBI population,(b) the impact of the
      treatment on everyday functioning, (c) the long term efficacy of the treatment and (c) the
      utility of booster sessions in facilitating long-term treatment effects. The investigators
      will randomly assign individuals with TBI, with documented impairment in new learning
      abilities, to a memory retraining group or a placebo control group. Both groups will undergo
      baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional
      neuropsychological battery and (2) an assessment of global functioning examining the impact
      of the treatment on daily activities. This design will allow us to evaluate the efficacy of
      this particular memory retraining technique in a TBI population through the assessment of
      cognitive function via a standard evaluation. In addition, the investigators will be able to
      draw conclusions regarding the impact of this particular memory remediation program on
      everyday life from questionnaires completed by the participant and a significant other.
      Optional enrollment in pre/post neuroimaging will also allow us to look at changes in the
      brain.
    

Detailed description: 
      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.
    

Intervention name(s): memory retraining exercises; placebo control memory exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).; Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 placebo control sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: memory; learning; Traumatic Brain Injury; cognition; treatment; therapy