NCT06068582 Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis
| NCT ID | NCT06068582 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2023-04-16 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 270 participants in total. It began in 2023-04-16 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Hanneke E Hulst
PRINCIPAL INVESTIGATOR
Leiden University
Frequently Asked Questions
Who can join the NCT06068582 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 67 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06068582 currently recruiting?
Yes, NCT06068582 is actively recruiting participants. Contact the research team at j.aarts@fsw.leidenuniv.nl for enrollment information.
Where is the NCT06068582 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06068582 clinical trial?
NCT06068582 is sponsored by Amsterdam UMC, location VUmc. The principal investigator is Hanneke E Hulst at Leiden University. The trial plans to enroll 270 participants.
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