Computerized Cognitive Rehabilitation in MS Patients
Purpose
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.
Conditions
- Multiple Sclerosis
- Cognitive Impairment
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of multiple sclerosis with cognitive complaint
Exclusion Criteria
- 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Placebo controlled
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
Computerized Cognitive Rehabilitation |
|
|
Sham Comparator Placebo |
Video game |
|
Recruiting Locations
New Brunswick, New Jersey 08091
Vikram Bhise, MD
732-235-7875
More Details
- NCT ID
- NCT03729713
- Status
- Recruiting
- Sponsor
- Rutgers, The State University of New Jersey
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.