Actively Recruiting

Phase Not Applicable
Age: 18Years - 67Years
All Genders
NCT06068582

Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis

Led by Amsterdam UMC, location VUmc · Updated on 2025-04-03

270

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

Sponsors

A

Amsterdam UMC, location VUmc

Lead Sponsor

U

Universiteit Leiden

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis

Who Can Participate

Age: 18Years - 67Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed MS diagnosis according to the McDonald 2017 criteria
  • Age between 18 and 67
  • No changes in disease modifying therapy in the last 3 months prior to inclusion
  • No current relapse or steroid treatment in the six weeks before study visits
  • Presence of mild cognitive deficits (at least one test with a Z-score between -1.0 and -1.99 on MACFIMS battery)
  • Ability to participate in exercise intervention (EDSS less than 6.0)
  • Meeting MRI safety criteria (no metal in body, not pregnant, no claustrophobia)
Not Eligible

You will not qualify if you...

  • Presence of neurological disorders other than MS or psychiatric disorders
  • Current or past history of drug or alcohol abuse
  • Unable to speak or read Dutch
  • Currently on sick leave for 6 weeks or longer
  • Currently pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Amsterdam University Medical Centers, location VUmc

Amsterdam, Netherlands

Actively Recruiting

Loading map...

Research Team

J

Jip Aarts

CONTACT

S

Shalina Saddal

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here