Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment: A Randomized Clinical Trial

Conditions
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Traumatic Brain Injury, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Speed of Processing Training
* Behavioral: Placebo Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Computerized exercised will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). | Behavioral: Speed of Processing Training<br> <br> |
| Placebo Comparator: Placebo control group<br>Computerized exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). | Behavioral: Placebo Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symbol-Digit Modalities Test | Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test | Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBI Quality of Life, Depression scale | Change in scores on self-report of emotional functioning, measured via questionnaire. The TBI QOL Depression scale measures depression. The range is 1-40. A higher score indicates greater depression. | Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention | 
| Perceived Deficits Questionnaire | Change in scores on self-report of perceived cognitive deficits in daily life, measured via questionnaire. A higher score indicates greater perceived deficits in daily life. Range of scores on the scale is 0-80. | Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention | 
| TBI Quality of Life, Total Score | Change in scores on self-report of quality of life, measured via questionnaire. DV is the TBI-QOL total score. The range is 1-40. A higher score indicates better quality of life. | Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Processing Speed, Cognition, Intervention, Traumatic Brain Injury, Mild Cognitive Impairment