Clinical trial NCT03729713: Computerized Cognitive Rehabilitation in MS Patients
Official title: Computerized Cognitive Rehabilitation in MS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Cognitive Impairment
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Horizon Blue Cross Blue Shield of New Jersey
First posted: 2018-11-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Placebo controlled
Primary purpose: TREATMENT

Brief summary: This study examines a home-based computerized cognitive rehabilitation intervention in adults with multiple sclerosis compared to placebo (videogame). Patients are assessed through pre-and post neuropsychological testing.

Detailed description: Patients will be randomized to enter a 6 week course of computer based cognitive rehabilitation focused on improving attention, learning, and memory. Control patients will receive an alternative home-based computer program not designed for cognitive remediation but of the same duration.

The primary outcome will be performance on neuropsychological testing in the intervention sample compared to controls. Secondary outcomes will be the measures of self-efficacy, work productivity, quality of life, fatigue, depression, anxiety, and healthcare utilization. Healthcare utilization variables include annual total cost (current year and prior), number and cost of ER/hospital/outpatient visits, number of hospital visits, hospital length of stay, number preventive visits, total number claims, and number of new medications initiated. In addition, acute changes in neuropsychological testing induced by a bout of physical activity (i.e. self-paced walking during the Six-Minute Walk Test) will be examined, and that pattern of change will be compared between intervention and control groups at each data collection point.

Each subject will participate for a total of 6 months.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of multiple sclerosis with cognitive complaint

Exclusion Criteria:

1. Patients unwilling to participate
2. Patients who cannot attend NPT sessions
3. Patients with severe cognitive impairment
4. Non-English speaking patients (testing materials are in English)
5. Patients with intact neuropsychological functioning at baseline on testing

Primary outcomes:
measure: Cognitive Functioning
timeFrame: 6 Months
Secondary outcomes:
measure: Multiple Sclerosis Self-Efficacy Scale
timeFrame: 6 Months
measure: Work Productivity and Activity Impairment Instrument
timeFrame: 6 months
measure: Multiple Sclerosis Quality of Life Inventory
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 6 months
measure: Healthcare Utilization
timeFrame: 12 Months
Other outcomes:
measure: Six-minute Walk Test
timeFrame: 6 months
measure: Timed Up & Go Test
timeFrame: 6 months
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
Study officials:
References: