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Computerized Cognitive Rehabilitation in MS Patients

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ClinicalTrials.gov Identifier: NCT03729713
Recruitment Status : Enrolling by invitation
First Posted : November 5, 2018
Last Update Posted : May 24, 2021
Sponsor:
Collaborator:
Horizon Blue Cross Blue Shield of New Jersey
Information provided by (Responsible Party):
Vikram Bhise, MD, 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Cognitive Impairment Other: Computerized cognitive rehabilitation Other: Sham placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computerized Cognitive Rehabilitation in MS Patients
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Cognitive Functioning [ Time Frame: 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 :
  1. Multiple Sclerosis Self-Efficacy Scale [ Time Frame: 6 Months ]
    Measures the person's perspective on maintenance and control over their multiple sclerosis

  2. Work Productivity and Activity Impairment Instrument [ Time Frame: 6 months ]
    Measures a person's impairments in their ability to work and participate in chosen activities

  3. Multiple Sclerosis Quality of Life Inventory [ Time Frame: 6 months ]
    A battery of quality of life scales designed for use by people with MS

  4. Hospital Anxiety and Depression Scale [ Time Frame: 6 months ]
    Measures depression and anxiety

  5. Healthcare Utilization [ Time Frame: 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


Other Outcome Measures:
  1. Six-minute Walk Test [ Time Frame: 6 months ]
    A measure of walking endurance - measures how far a person can walk in six minutes

  2. Timed Up & Go Test [ Time Frame: 6 months ]
    A timed test of functional mobility that tests a persons ability to stand, walk a short distance and return to sitting.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729713


Locations
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United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08091
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Horizon Blue Cross Blue Shield of New Jersey
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Responsible Party: Vikram Bhise, MD, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03729713    
Other Study ID Numbers: 2018001642
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases