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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020564
Recruitment Status : Active, not recruiting
First Posted : December 25, 2013
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 12, 2012
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. TBI Quality of Life, Depression scale [ Time Frame: 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.

  2. Perceived Deficits Questionnaire [ Time Frame: 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.

  3. TBI Quality of Life, Total Score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020564


Locations
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United States, New Jersey
Kessler Foundation
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Kessler Foundation
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Responsible Party: Nancy Chiaravalloti, Director, Neuropsychology & Neuroscience; Director, Traumatic Brain Injury Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT02020564    
Other Study ID Numbers: R-755-12
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Keywords provided by Nancy Chiaravalloti, Kessler Foundation:
Processing Speed
Cognition
Intervention
Traumatic Brain Injury
Mild Cognitive Impairment
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cognition Disorders
Neurocognitive Disorders
Mental Disorders