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

Sponsor

Kessler Foundation (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02020564

Collaborator

(none)

Enrollment

Location

Arms

120.6

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Mild Cognitive Impairment	Behavioral: Speed of Processing Training Behavioral: Placebo Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 12, 2012

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment Group

Computerized exercised will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Behavioral: Speed of Processing Training

Placebo Comparator: Placebo control group

Computerized exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Behavioral: Placebo Control

Outcome Measures

Primary Outcome Measures

Symbol-Digit Modalities Test [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 Outcome Measures

TBI Quality of Life, Depression scale [Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention]
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.
Perceived Deficits Questionnaire [Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention]
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.
TBI Quality of Life, Total Score [Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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