Computerized Cognitive Rehabilitation in MS Patients

Not Applicable

Recruiting

• Conditions: Cognitive Impairment; Multiple Sclerosis

• Registration Number: NCT03729713
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-05
• Study Start: 2021-04-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17
• Primary Completion: 2023-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cognitive Functioning	6 Months	Compare between groups differences in attention (auditory and visual working memory), processing speed (automatic and controlled speed), executive functioning (verbal fluency and mental flexibility), and memory (immediate and delayed verbal and visual modalities) at completion of intervention, 3 months and 6 months using standardized scores.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	6 months	Measures depression and anxiety
Healthcare Utilization	12 Months	Compare between group differences in annual cost of care, ER visits, hospital visits, hospital length of stay, number of preventive visits, total number of claims, and neurology office visits
Multiple Sclerosis Self-Efficacy Scale	6 Months	Measures the person's perspective on maintenance and control over their multiple sclerosis
Work Productivity and Activity Impairment Instrument	6 months	Measures a person's impairments in their ability to work and participate in chosen activities
Multiple Sclerosis Quality of Life Inventory	6 months	A battery of quality of life scales designed for use by people with MS

Trial Locations

Locations (1)

Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States