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

Primary Purpose

Traumatic Brain Injury, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speed of Processing Training
Placebo Control
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Processing Speed, Cognition, Intervention, Traumatic Brain Injury, Mild Cognitive Impairment

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Placebo control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Symbol-Digit Modalities Test
Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 19, 2013
Last Updated
January 16, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02020564
Brief Title
Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment
Official Title
Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 12, 2012 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Mild Cognitive Impairment
Keywords
Processing Speed, Cognition, Intervention, Traumatic Brain Injury, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Computerized exercised will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Arm Title
Placebo control group
Arm Type
Placebo Comparator
Arm Description
Computerized exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Intervention Type
Behavioral
Intervention Name(s)
Speed of Processing Training
Intervention Type
Behavioral
Intervention Name(s)
Placebo Control
Primary Outcome Measure Information:
Title
Symbol-Digit Modalities Test
Description
Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test
Time Frame
Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Secondary Outcome Measure Information:
Title
TBI Quality of Life, Depression scale
Description
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.
Time Frame
Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Title
Perceived Deficits Questionnaire
Description
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.
Time Frame
Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Title
TBI Quality of Life, Total Score
Description
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.
Time Frame
Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

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

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