BridgeMD
New treatment option for Multiple Sclerosis
Official title Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis
ClinicalTrials.gov ID: NCT06068582
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 67
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 67 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.