Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Kessler Foundation
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Symbol-Digit Modalities Test
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this research study is to investigate the effectiveness of a technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how well this technique can help people with TBI increase their processing speed and their ability to function better in everyday life.
Detailed Description
The current proposal is designed to apply this treatment protocol to a large sample of individuals with moderate to severe TBI with documented impairment in PS. The goals of the trial are to (a) test the efficacy of this treatment protocol within a TBI population, (b) evaluate the impact of the treatment on everyday functioning, (c) evaluate the longer-term efficacy of the treatment, and (d) examine the utility of booster sessions in facilitating longer-term treatment effects. Individuals with moderate to severe TBI, with documented impairment in PS, will be randomly assigned to a treatment group or a control group. Both groups will undergo baseline, immediate post-treatment and long-term follow-up assessment consisting of: (1) a standardized neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to assess the efficacy of SPT in persons with TBI and evaluate its impact on everyday life.
Investigators
Nancy Chiaravalloti
Director, Neuropsychology & Neuroscience; Director, Traumatic Brain Injury Research
Kessler Foundation
Eligibility Criteria
Inclusion Criteria
- •diagnosis of Traumatic Brain Injury or Mild cognitive impairment
- •Fluent in English
- •processing speed impairment
Exclusion Criteria
- •prior stroke or neurological disease
- •currently taking steroids and/or benzodiazepines
- •history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or pyschosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
- •significant alcohol or drug abuse history
Outcomes
Primary Outcomes
Symbol-Digit Modalities Test
Time Frame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test
Secondary Outcomes
- TBI Quality of Life, Total Score(Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention)
- TBI Quality of Life, Depression scale(Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention)
- Perceived Deficits Questionnaire(Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention)