Improving New Learning and Memory in Traumatic Brain Injury

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.

Conditions

• Traumatic Brain Injury

Interventions

BEHAVIORAL

memory retraining exercises

Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training 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.

Sponsors & Collaborators

• U.S. Department of Education

  collaborator FED

• Kessler Foundation

  lead OTHER

Principal Investigators

• Nancy D Chiaravalloti, Ph.D. · Kessler Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• United States

Study Locations