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
- Diseases
- Multiple sclerosis
- 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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Department, Reha Rheinfelden Coordinator of this site? Confirm its status | Rheinfelden | Switzerland | Not yet recruiting |
| Health, Medical and Neuropsychology, Institute of Psychology, Faculty of Behvavioural and Social Siences, Leiden University Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo Coordinator of this site? Confirm its status | Buffalo | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.