Postponing cognitive decline and preventing early unemployment in patients with multiple sclerosis - strengthening the brain and mind (part of the Don't be late! study)

Recruiting

• Conditions: MS; Multiple Sclerosis; 10003816; 10012303

• Registration Number: NL-OMON53491
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 270

Inclusion Criteria

- Confirmed MS diagnosis according to McDonald 2017 criteria
- Age between 18 and 67
- No changes in disease modifying therapy prior to inclusion (i.e. no changes
in last 3 months)
- No current relapse or steroid treatment in the six weeks prior to the study
visits
- Sublinical cognitive impairment

Exclusion Criteria

- Patients with neurological (other than MS) and psychiatric disorders
- A current or history of drug or alcohol abuse
- Being unable to speak or read in Dutch
- Currently on sick leave and working for less than 12 hours for a period of 3
months or longer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is change in quality of life as measured with the 36-item<br /><br>Short Form.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in cognitive performance (as measured with the neuropsychological<br /><br>examination) will serve as secundary parameter. Additionally, changes on<br /><br>questionnaires (concerning neuropsychological symptoms, work challenges and<br /><br>participation, fatigue, anxiety and depression, resilience, stress and worry,<br /><br>ability to participate in social roles and activity) will be included. Brain<br /><br>changes will also be observed using MRI.</p><br>