Improving New Learning and Memory in Traumatic Brain Injury

Improving New Learning in Traumatic Brain Injury: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: memory retraining exercises; Behavioral: placebo control memory exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).	Behavioral: memory retraining exercises; Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Placebo Comparator: Placebo control group; The placebo control group will receive placebo memory exercises administered on a laptop computer twice a week for five weeks (10 placebo control sessions).	Behavioral: placebo control memory exercises; Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 placebo control sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Scores on memory tests	Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed

Secondary Outcome Measures

Outcome Measure	Time Frame
Reports of emotional functioning, memory functioning and quality of life	Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: U.S. Department of Education
• Investigators: Principal Investigator: Nancy D Chiaravalloti, Ph.D., Kessler Foundation

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: September 21, 2010
• First Submitted That Met QC Criteria: September 21, 2010
• First Posted (Estimate): September 22, 2010

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: memory; treatment; cognition; learning; Traumatic Brain Injury; therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: ndcnidrr2007