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Improving New Learning and Memory in Traumatic Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01207375
First Posted: September 22, 2010
Last Update Posted: April 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation
  Purpose
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.

Condition Intervention
Traumatic Brain Injury Behavioral: memory retraining exercises Behavioral: placebo control memory exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving New Learning in Traumatic Brain Injury: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Nancy Chiaravalloti, Kessler Foundation:

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

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

Estimated Enrollment: 120
Study Start Date: January 2008
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207375


Locations
United States, New Jersey
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
U.S. Department of Education
Investigators
Principal Investigator: Nancy D Chiaravalloti, Ph.D. Kessler Foundation
  More Information

Responsible Party: Nancy Chiaravalloti, Director, Neuropsychology & Neuroscience Lab, Kessler Foundation
ClinicalTrials.gov Identifier: NCT01207375     History of Changes
Other Study ID Numbers: ndcnidrr2007
First Submitted: September 21, 2010
First Posted: September 22, 2010
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Nancy Chiaravalloti, Kessler Foundation:
memory
learning
Traumatic Brain Injury
cognition
treatment
therapy

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System