Computerized Cognitive Rehabilitation in MS Patients

NCT ID: NCT03729713

Last Updated: 2022-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Computerized Cognitive Rehabilitation

Group Type EXPERIMENTAL

Computerized cognitive rehabilitation

Intervention Type OTHER

6 week course of cognitive rehabilitation focused on attention, learning, and memory

Placebo

Video game

Group Type SHAM_COMPARATOR

Sham placebo

Intervention Type OTHER

an alternative home-based computer program not designed for cognitive remediation but of the same duration

Interventions

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Computerized cognitive rehabilitation

6 week course of cognitive rehabilitation focused on attention, learning, and memory

Intervention Type OTHER

Sham placebo

an alternative home-based computer program not designed for cognitive remediation but of the same duration

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Horizon Blue Cross Blue Shield of New Jersey

OTHER

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Vikram Bhise, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vikram Bhise, MD

Role: CONTACT

7322357875

Facility Contacts

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Vikram Bhise, MD

Role: primary

732-235-7875

Other Identifiers

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2018001642

Identifier Type: -

Identifier Source: org_study_id

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