Trials / Unknown
UnknownNCT03729713
Computerized Cognitive Rehabilitation in MS Patients
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Rutgers, The State University of New Jersey · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Computerized cognitive rehabilitation | 6 week course of cognitive rehabilitation focused on attention, learning, and memory |
| OTHER | Sham placebo | an alternative home-based computer program not designed for cognitive remediation but of the same duration |
Timeline
- Start date
- 2021-04-21
- Primary completion
- 2023-05-01
- Completion
- 2024-05-01
- First posted
- 2018-11-05
- Last updated
- 2022-11-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03729713. Inclusion in this directory is not an endorsement.