No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
Universiteit Leiden · Other
Who this trial is looking for
This trial is looking for people with Multiple Sclerosis who experience memory and concentration issues. Participants will use an app-based training program for 12 weeks followed by a 6-week cognitive rehabilitation program.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with relapsing remitting or secondary progressive MS.
I am between 18 and 65 years old.
I speak Dutch, English, or German.
I have an EDSS score of less than 7.
I have not had a relapse in the past 3 months.
I have been on an unchanged disease-modifying therapy for at least 2 months.
You may not be able to join if
I have a score of 65 or higher for conscientiousness on a personality test.
I have had a brain injury or other neurological condition.
I have a psychiatric disorder that affects my daily functioning.
I take medications that impact my cognitive functioning.
I cannot have an MRI due to medical reasons.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 fu…
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).
Trial Locations
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Status
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-…
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
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