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

• ClinicalTrials.gov Identifier: NCT02020564
• Recruitment Status: Active, not recruiting
• First Posted: December 25, 2013
• Last Update Posted: October 23, 2019
• Sponsor: Kessler Foundation
• Information provided by (Responsible Party): Nancy Chiaravalloti, Kessler Foundation

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	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.

Study Design

• 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

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, New Jersey

Kessler Foundation

East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Kessler Foundation

More Information

• 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
• 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:

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