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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 67
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Netherlands
Amsterdam University Medical Centers, location VUmc
RECRUITING
Amsterdam
Contact Information
Primary
Jip Aarts
j.aarts@fsw.leidenuniv.nl
+31 71 5275081
Backup
Shalina Saddal
s.saddal@amsterdamumc.nl
+31 20 566 38 01
Time Frame
Start Date: 2023-04-16
Estimated Completion Date: 2026-09
Participants
Target number of participants: 270
Treatments
Experimental: Strengthening the brain
Participants receive 30 minutes of 1-on-1 fitness training, dietary advice, and mental coaching, in addition to twice 20 minutes fitness at home, and 60 minutes of cognitive training each week for four months.
Experimental: Strengthening the mind
Partiicpants receive biweekly 1-on-1 coaching by a trained work-coach who has MS to identify challenges at work and implement solutions. It is completed when satisfactory solutions have been implemented for all challenges or after four months.
No_intervention: Enhanced usual care
Participants receiving general information about cognitive impairment in MS and following care as usual for four months.
Related Therapeutic Areas
Sponsors
Collaborators: MS Sherpa, Merck BV, Genzyme, a Sanofi Company, Personal Fitness Nederland, MS Vereniging Nederland, Universiteit Leiden
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov