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

Kessler Foundation

Status: Completed

Conditions: Traumatic Brain Injury; Mild Cognitive Impairment

Treatments: Behavioral: Placebo Control; Behavioral: Speed of Processing Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02020564

R-755-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

Computerized exercised will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Treatment:

Behavioral: Speed of Processing Training

Placebo control group

Placebo Comparator group

Description:

Computerized exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Treatment:

Behavioral: Placebo Control