Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis
Recruiting · NCT06068582 · Interventional (participants receive a specific treatment) · Lead sponsor: Amsterdam UMC, location VUmc
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Amsterdam University Medical Centers, location VUmc - Amsterdam, Netherlands