Improving New Learning and Memory in Traumatic Brain Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT01207375
First received: September 21, 2010
Last updated: April 4, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2008
Estimated Study Completion Date: October 2014
Estimated 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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nancy Chiaravalloti, Director, Neuropsychology & Neuroscience Lab, Kessler Foundation
ClinicalTrials.gov Identifier: NCT01207375     History of Changes
Other Study ID Numbers: ndcnidrr2007
Study First Received: September 21, 2010
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 31, 2014