Computerized Cognitive Rehabilitation in MS Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Cognitive Impairment
• Intervention / Treatment: Other: Computerized cognitive rehabilitation; Other: Sham placebo

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vikram Bhise, MD; Phone Number: 7322357875; Email: MSCogStudy@outlook.com

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08091
      • Recruiting
      • Robert Wood Johnson Medical School
      • Contact: Vikram Bhise, MD; Phone Number: 732-235-7875
      • Principal Investigator: Vikram Bhise, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Computerized Cognitive Rehabilitation	Other: Computerized cognitive rehabilitation; 6 week course of cognitive rehabilitation focused on attention, learning, and memory
Sham Comparator: Placebo; Video game	Other: Sham placebo; an alternative home-based computer program not designed for cognitive remediation but of the same duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Functioning	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.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple Sclerosis Self-Efficacy Scale	Measures the person's perspective on maintenance and control over their multiple sclerosis	6 Months
Work Productivity and Activity Impairment Instrument	Measures a person's impairments in their ability to work and participate in chosen activities	6 months
Multiple Sclerosis Quality of Life Inventory	A battery of quality of life scales designed for use by people with MS	6 months
Hospital Anxiety and Depression Scale	Measures depression and anxiety	6 months
Healthcare Utilization	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	12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute Walk Test	A measure of walking endurance - measures how far a person can walk in six minutes	6 months
Timed Up & Go Test	A timed test of functional mobility that tests a persons ability to stand, walk a short distance and return to sitting.	6 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Horizon Blue Cross Blue Shield of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: 2018001642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No