Improving New Learning and Memory in Traumatic Brain Injury

NCT01207375 | Completed DMC

• 1 other identifier: ndcnidrr2007
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

memory; learning; Traumatic Brain Injury; cognition; treatment; therapy

Outcome Measures

Primary Outcomes (1)

• Scores on memory tests

  Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed

Secondary Outcomes (1)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

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

Placebo control group

PLACEBO COMPARATOR

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

Interventions

memory retraining exercises BEHAVIORAL

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

experimental group

placebo control memory exercises BEHAVIORAL

Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 placebo control sessions.

Placebo control group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English as primary language
• Diagnosis of TBI, at least one year post-injury

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Nancy D Chiaravalloti, Ph.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neuropsychology & Neuroscience Lab

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: January 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

US (1)