Computerized Cognitive Rehabilitation in MS Patients

Multiple Sclerosis Clinical Trial

Official title:

Computerized Cognitive Rehabilitation in MS Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03729713
• Other study ID #: 2018001642
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: May 2024

Study information

• Verified date: November 2022
• Source: Rutgers, The State University of New Jersey
• Contact: Vikram Bhise, MD
• Phone: 7322357875
• Email: MSCogStudy[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Multiple Sclerosis

Intervention

Other:
• Computerized cognitive rehabilitation
6 week course of cognitive rehabilitation focused on attention, learning, and memory
• Sham placebo
an alternative home-based computer program not designed for cognitive remediation but of the same duration

Locations

Country	Name	City	State
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Horizon Blue Cross Blue Shield of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Six-minute Walk Test	A measure of walking endurance - measures how far a person can walk in six minutes	6 months
Other	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
Primary	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	Multiple Sclerosis Self-Efficacy Scale	Measures the person's perspective on maintenance and control over their multiple sclerosis	6 Months
Secondary	Work Productivity and Activity Impairment Instrument	Measures a person's impairments in their ability to work and participate in chosen activities	6 months
Secondary	Multiple Sclerosis Quality of Life Inventory	A battery of quality of life scales designed for use by people with MS	6 months
Secondary	Hospital Anxiety and Depression Scale	Measures depression and anxiety	6 months
Secondary	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