Preventing cognitive decline and unemployment in people with multiple sclerosis
Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis
NA · Amsterdam UMC, location VUmc · NCT06068582
This study is testing two new programs to see if they can help people with multiple sclerosis keep their thinking skills sharp and stay employed, compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 67 Years |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc (other) |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06068582 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of two innovative interventions designed to prevent cognitive decline and work-related issues in individuals with multiple sclerosis (MS) compared to enhanced usual care. Participants will engage in interventions focused on strengthening cognitive and psychological functions over a four-month period, with follow-up assessments at six and twelve months post-intervention. The study will also explore predictive factors for intervention response and gather qualitative feedback from stakeholders to facilitate clinical implementation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 67 with a confirmed diagnosis of multiple sclerosis and mild cognitive deficits.
Not a fit: Patients with severe cognitive impairments or other neurological and psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for individuals with multiple sclerosis by delaying cognitive decline and enhancing employment outcomes.
How similar studies have performed: Previous studies have shown promise in using cognitive and psychological interventions for individuals with multiple sclerosis, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed MS diagnosis according to the 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) - this criterion only applies at inclusion to ensure participants are in a stable situation at the start of the study and for follow-up measures, changes in treatment will be registered but will not result in exclusion from the study * no current relapse or steroid treatment in the six weeks prior to study visits * presence of mild cognitive deficits (at least one test with a Z-score of -1.0 to -1.99 below norm scores of healthy controls on the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery * being able to participate in an exercise intervention (i.e., EDSS \< 6.0) * fulfilling safety criteria for MRI (no metal inside body, not pregnant, no claustrophobia) Exclusion Criteria: * presence of neurological (other than MS) and psychiatric disorders * a current or history of drug or alcohol abuse * being unable to speak or read Dutch * currently on sick leave for a period of 6 weeks or longer * currently pregnant
Where this trial is running
Amsterdam
- Amsterdam University Medical Centers, location VUmc — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Hanneke E Hulst — Leiden University
- Study coordinator: Jip Aarts
- Email: j.aarts@fsw.leidenuniv.nl
- Phone: +31 71 5275081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Cognition, Exercise, Employment, Prevention, Health-related Quality of Life