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Completed

NCT Number: NCT02020564

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Craniocerebral Trauma Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

East Hanover, New Jersey, 07936, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Speed of Processing Training

Behavioral

Placebo control

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Dec 25, 2013
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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