Preventing cognitive decline and unemployment in people with multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Cooling During Inpatient Rehab for People with MS

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.