Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires, MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI."
- "The confined space inside the MRI device for the duration of 25 minutes of the scan as well as the time investment of the participant for travel to study location and participation involves some burden for the participants."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * High conscientiousness, measured with a T score 65 or higher on the BFI-2 subscale for conscientiousness * Current or prior brain trauma or neurological condition (other than MS) * Psychiatric disorder that heavily impacts cognitive and/or daily functioning * Medication intake and/or substance abuse that has an influence on cognitive functioning * For Dutch subsample undergoing MRI: Contradiction for MRI
Study sites (1)
NY
- Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo · Buffalo, NY 14203Ralph HB Benedict, Prof · Study contact · 716-323-0556 · benedict@buffalo.eduRalph HB Benedict, Prof · Principal investigatorMore trials in Buffalo