Development and application of a digital integrated diagnostics and rehablitation toolbox to treat cognitive deficits in healthy adults and in patients with multiple sclerosis.

Development and application of a digital integrated diagnostics and rehablitation toolbox to treat cognitive deficits in healthy adults and in patients with multiple sclerosis. - BRAIN

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017661

Enrollment

150

Registered

2020-01-08

Start date

2019-08-20

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G35.10

Interventions

Group 1: 50 multiple sclerosis patients

Neuropsychological testing (BICAMS, SDMT, BRB-N, PASAT, Stroop) and computer-based testing using the developed BRAIN app on days 0 and 1. Then cognitive training using the BRAIN app twice a week for 4

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: - Written consent to participate - Patients with multiple sclerosis (according to McDonald 2017 (Thompson et al. 2018)) and clinically demonstrable, documented cognitive deficits - existing health insurance to clarify possible incidental findings - Adequate understanding and use of the German language for information and instructions and neuropsychological tests

Exclusion criteria

Exclusion criteria: - lack/withdrawal of consent - Cognitive deficits by other diseases apart from multiple sclerosis - other serious neurological disorders - psychiatric disorders - serious internal disorders - Non-MRI-capable patients / subjects (e.g. people with claustrophobia, carriers of certain metallic foreign bodies, electronic devices and / or tattoos) - Pregnant and breastfeeding women

Design outcomes

Primary

Measure	Time frame
Acceptance, adherence and dropout rate of the cross-sectional and longitudinal use of the digital toolbox of healthy subjects and multiple sclerosis patients with cognitive deficits, measured with the help of compliance rates.	—

Secondary

Measure	Time frame
• Determination of toolbox-based operationalized endpoints for the quantification of cognitive deficits in the domains: verbal short-term and long-term memory, non-verbal thinking, cognitive processing speed, visual-spatial long-term memory, working memory, attention, inhibition / executive functions • Results of the following validated and standardized neuropsychological paper-pencil tests for the diagnosis of cognitive deficits: Brief International Cognitive Assessment for MS (BICAMS) / Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Symbol Digit Modalities Test (SDMT), Paced Auditory Serial Addition Test (PASAT) 2 and PASAT 3 • Change of the toolbox-based parameters as well as the results obtained with paper-pencil tests after 1, 2 and 3 months under rehabilitation with the help of the developed toolbox, measured on the basis of initial and difference values, regression towards the middle and negative correlation of initial and difference values for measuring the training effect. • Effect size r and power to calculate the number of cases for future controlled intervention studies to determine the differences between a healthy control cohort and patients with cognitive deficits and to identify positive and negative changes in cognitive performance during rehabilitation during the course. • MRI-based parameters: functional connectivity, diffusion tensor imaging (DTI) with fractional anisotropy (FA) and voxel-based morphometry, in particular the hippocampus formation and associated regions. • Results of the questionnaires on quality of life (NeuroQoL, SF36) and ability to work. Results of the summarizing qualitative content analysis of the questionnaires to the experienced medical and (neuro) psychological user network.	—

Measure

Time frame

• Determination of toolbox-based operationalized endpoints for the quantification of cognitive deficits in the domains: verbal short-term and long-term memory, non-verbal thinking, cognitive processing speed, visual-spatial long-term memory, working memory, attention, inhibition / executive functions • Results of the following validated and standardized neuropsychological paper-pencil tests for the diagnosis of cognitive deficits: Brief International Cognitive Assessment for MS (BICAMS) / Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Symbol Digit Modalities Test (SDMT), Paced Auditory Serial Addition Test (PASAT) 2 and PASAT 3 • Change of the toolbox-based parameters as well as the results obtained with paper-pencil tests after 1, 2 and 3 months under rehabilitation with the help of the developed toolbox, measured on the basis of initial and difference values, regression towards the middle and negative correlation of initial and difference values for measuring the training effect. • Effect size r and power to calculate the number of cases for future controlled intervention studies to determine the differences between a healthy control cohort and patients with cognitive deficits and to identify positive and negative changes in cognitive performance during rehabilitation during the course. • MRI-based parameters: functional connectivity, diffusion tensor imaging (DTI) with fractional anisotropy (FA) and voxel-based morphometry, in particular the hippocampus formation and associated regions. • Results of the questionnaires on quality of life (NeuroQoL, SF36) and ability to work. Results of the summarizing qualitative content analysis of the questionnaires to the experienced medical and (neuro) psychological user network.

—

Countries

Germany

Contacts

Public ContactJoseph Kuchling

Klinik für NeurologieCharité-Universitätsmedizin Berlin

joseph.kuchling@charite.de030-450 639 808

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026