Computerized Cognitive Rehabilitation in MS Patients

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Cognitive Impairment; Multiple Sclerosis

Treatments: Other: Sham placebo; Other: Computerized cognitive rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03729713

2018001642

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Intervention

Experimental group

Description:

Computerized Cognitive Rehabilitation

Treatment:

Other: Computerized cognitive rehabilitation

Placebo

Sham Comparator group

Description:

Video game

Treatment:

Other: Sham placebo