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NCT07225868Recruiting

Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?

Source: ClinicalTrials.gov · Last updated 10 Nov 2025

Brief summary (registry, in English)

People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation. Recently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account. In this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved. This study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
126 (estimated)
First submitted
3 Nov 2025
Start date
1 Nov 2025
Primary completion date
31 Dec 2028
Lead sponsor
Universiteit Leiden
NCT number
NCT07225868

What you commit to

  • Study type: Interventional
  • Planned participants: 126
  • From 1 Nov 2025 to the primary completion date, 31 Dec 2028
  • 3 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or prior brain trauma or neurological condition (other than MS)
  • Medication intake and/or substance abuse that has an influence on cognitive functioning

Other illness

  • Psychiatric disorder that heavily impacts cognitive and/or daily functioning

Other

  • High conscientiousness, measured with a T score 65 or higher on the BFI-2 subscale for conscientiousness
  • For Dutch subsample undergoing MRI: Contradiction for MRI

Who the study is looking for

  • Confirmed relapsing remitting or secondary progressive MS diagnosis according to the McDonald 2017 criteria
  • Expanded Disability Status Scale (EDSS) score \< 7
  • Relapse free period ≥ 3 months
  • Unchanged disease modifying therapy for ≥ 2 months at time of inclusion
  • Age 18-65 years
  • Language Dutch, English or German for each centre respectively

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Research Department, Reha Rheinfelden
Coordinator of this site? Confirm its status
RheinfeldenSwitzerlandNot yet recruiting
Health, Medical and Neuropsychology, Institute of Psychology, Faculty of Behvavioural and Social Siences, Leiden University
Coordinator of this site? Confirm its status
LeidenNetherlandsRecruiting
Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo
Coordinator of this site? Confirm its status
BuffaloUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.