Improving New Learning and Memory in Traumatic Brain Injury
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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 |
- 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 ]
- 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: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (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 |
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| Contact: Nancy D Chiaravalloti, Ph.D. | 973-324-8440 | nchiaravalloti@kesslerfoundation.org |
| Contact: Angela A Smith, M.A. | 973-324-8448 | asmith@kesslerfoundation.org |
| United States, New Jersey | |
| Kessler Foundation Research Center | Recruiting |
| West Orange, New Jersey, United States, 07052 | |
| Contact: Angela A Smith, M.A. 973-324-8448 asmith@kesslerfoundation.org | |
| Contact: Nancy D Chiaravalloti, Ph.D. 973-324-8440 nchiaravalloti@kesslerfoundation.org | |
| Principal Investigator: Nancy D Chiaravalloti, Ph.D. | |
| 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: | May 11, 2012 |
| 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 Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on June 17, 2013