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

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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Speed of Processing Training; Behavioral: Placebo Control

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symbol-Digit Modalities Test	Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test	Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
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.	Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
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.	Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2012
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 24, 2013
• First Posted (Estimate): December 25, 2013

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Cognition; Intervention; Processing Speed; Traumatic Brain Injury
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Cognition Disorders; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction
• Other Study ID Numbers: R-755-12