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Working memory in the presence of distraction in people with Multiple Sclerosis: underlying neural mechanisms of a novel paradigm

Working memory in the presence of distraction in people with Multiple Sclerosis: underlying neural mechanisms of a novel paradigm - Working Memory and Distraction in People with MS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53232
Enrollment
68
Registered
2023-07-12
Start date
2023-06-15
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'MS' 'Multiple Sclerosis'

Interventions

None listed

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: For PwMS: • Confirmed relapse onset MS diagnosis according to the McDonald 2017 criteria • Expanded Disability Status Scale (EDSS) score = 3 months • unchanged therapy for >= 2 months at time of inclusion. • Age 18-65 years • Language: Dutch • Pregnancy • Inability to use the right hand For healthy controls: • Age 18-65 years • Language: Dutch • Pregnancy • Inability to use the right hand

Exclusion criteria

Exclusion criteria: see inclusion criteria D4a.

Design outcomes

Primary

MeasureTime frame
The main endpoint measure of the study is the regional task-based Blood Oxygen Level Dependent (BOLD) response measured by fMRI during a visual and verbal WM task paradigm with delayed distraction and distraction at encoding compared to the control condition without distraction (14).

Secondary

MeasureTime frame
The secondary endpoints measure target the behavioural and neural differences between PwMS and healthy controls in the visual and verbal WM task paradigm with delayed distraction and distraction at encoding. • Differences in regional task-based BOLD response changes measured by fMRI during a visual and verbal WM task paradigm with delayed distraction and distraction at encoding between PwMS and healthy controls • Differences in task performance of visual and verbal WM with delayed distraction and distraction at encoding between PwMS and healthy controls • Differences in resting state brain activity between PwMS and healthy controls Other study parameters include: • Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS(27)) in order to assess cognitive functioning in PwMS • Forward and backward digit span (WAIS-IV (28)) to assess phonological WM performance in all participants • Corsi Block Tapping Test (29,30) to assess visuospatial WM performance in all participants • Sensory Processing Sensitivity Questionnaire (38) to assess sensory processing sensitivity in all participants

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)