Clinical trial NCT02301260: Speed of Processing Training to Improve Cognition in Multiple Sclerosis
Official title: Speed of Processing Training to Improve Cognition in Multiple Sclerosis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Processing Speed
Intervention
Multiple Sclerosis
Cognition
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2014-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to investigate the effectiveness of a computerized technique designed to improve processing speed (i.e. the amount of time it takes for a person's brain to process information) in a multiple sclerosis (MS) population. The study is designed to study how well this technique can help people with MS increase their processing speed and their ability to function better in everyday life. This treatment protocol has been studied extensively with older adults, showing improvements on standard laboratory measures of processing speed and performance of activities of daily living.

Detailed description: This study is a double-blind, placebo-control randomized clinical trial examining the efficacy of Speed of Processing Training (SPT) for improving processing speed (PS) deficits in persons with Multiple Sclerosis (MS). Slowed PS is one of the most common deficits in individuals with MS and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to remediate PS deficits in order to improve the everyday functioning of individuals with MS. This study is designed to (1) apply a treatment protocol for PS impairments well-validated in an aging population to individuals with MS with objectively observable deficits in PS and document its efficacy on standard neuropsychological outcome measures. In addition, the investigators will (2) assess the effectiveness of the intervention utilizing global measures of everyday life, including an objective measure (the Timed Activities of Daily Living; TIADL), as well as additional questionnaires to be completed by both the participant and a significant other. This study is also designed to (3) examine the influence of degree of PS impairment on treatment efficacy using neuropsychological tests, (4) evaluate the long-term effects of the treatment protocol and (5) examine the utility of booster sessions to facilitate long-term treatment effects.

Eligibility criteria: Inclusion Criteria:

* English as a primary language
* diagnosis of Multiple Sclerosis
* processing speed impairment (based on evaluation)

Exclusion Criteria:

* most recent exacerbation within one month
* currently taking steroids or benzodiazepines
* history of significant psychiatric illness (bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder
* significant alcohol or drug abuse history

Primary outcomes:
measure: Change in scores on standardized tests of processing speed
timeFrame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
Secondary outcomes:
measure: Change in scores on self-report of emotional functioning, measured via questionnaire
timeFrame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
measure: Change in scores on self-report of everyday functioning, measured via questionnaire
timeFrame: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed
measure: Change in scores on self-report of quality of life, measured via questionnaire
timeFrame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Nancy Chiaravalloti, PhD
role: PRINCIPAL_INVESTIGATOR
References: