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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020564
• Other study ID #: R-755-12
• Status: Completed
• Phase: N/A
• Start date: December 12, 2012
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Speed of Processing Training

• Placebo Control

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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