NCT06068582Recruiting
Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this randomized controlled trial is to compare the effectiveness of two innovative interventions aimed at preventing cognitive decline and work-related problems to enhanced usual care in improving quality of life in people with multiple sclerosis. Secondary objectives are: * to compare the effectiveness of the investigated interventions in improving cognitive, psychological, and work functioning, and in enhancing the brain's functional network * to examine which factors (i.e., baseline cognitive, psychological, work, and brain MRI-parameters) are predictive of the response to the investigated interventions * aim to qualitatively reflect on the process and outcome of the investigated interventions considering the perspectives of relevant stakeholders to allow for smooth and successful implementation in clinical practice Participants will follow the intervention for four months, with follow-up measurements at six months after intervention and 12 months after intervention.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 25 Aug 2023
- Start date
- 16 Apr 2023
- Primary completion date
- Sept 2026
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Multiple sclerosis
- NCT number
- NCT06068582
What you commit to
- Study type: Interventional
- Planned participants: 270
- From 16 Apr 2023 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently on sick leave for a period of 6 weeks or longer
Other illness
- presence of neurological (other than MS) and psychiatric disorders
- a current or history of drug or alcohol abuse
Other
- being unable to speak or read Dutch
- currently pregnant
Who the study is looking for
- 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)
Age in the registry: 18 years to 67 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam University Medical Centers, location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.