Computerized Cognitive Rehabilitation in MS Patients
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Apr 2021
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 5, 2018
CompletedStudy Start
First participant enrolled
April 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedNovember 17, 2022
November 1, 2022
2 years
November 1, 2018
November 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Multiple Sclerosis Self-Efficacy Scale
6 Months
Work Productivity and Activity Impairment Instrument
6 months
Multiple Sclerosis Quality of Life Inventory
6 months
Hospital Anxiety and Depression Scale
6 months
Healthcare Utilization
12 Months
Other Outcomes (2)
Six-minute Walk Test
6 months
Timed Up & Go Test
6 months
Study Arms (2)
Intervention
EXPERIMENTALComputerized Cognitive Rehabilitation
Placebo
SHAM COMPARATORVideo game
Interventions
6 week course of cognitive rehabilitation focused on attention, learning, and memory
an alternative home-based computer program not designed for cognitive remediation but of the same duration
Eligibility Criteria
You may qualify if:
- \. Diagnosis of multiple sclerosis with cognitive complaint
You may not qualify if:
- Patients unwilling to participate
- Patients who cannot attend NPT sessions
- Patients with severe cognitive impairment
- Non-English speaking patients (testing materials are in English)
- Patients with intact neuropsychological functioning at baseline on testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08091, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 1, 2018
First Posted
November 5, 2018
Study Start
April 21, 2021
Primary Completion
May 1, 2023
Study Completion
May 1, 2024
Last Updated
November 17, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share