Cytokine State, Cognitive Decline and Cortical Degeneration in MS-Patients (Multiple Sclerosis)

Cytokine State, Cognitive Decline and Cortical Degeneration in MS-Patients (Multiple Sclerosis) - MS_CYCOG

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005625

Enrollment

210

Registered

2014-01-23

Start date

2014-12-09

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

Interventions

Group 1: Patients with Multiple Sclerosis (MS

70 Patients each group: early relapsing-remitting MS with low disability status EDSS=4.0, primary/secondary chronic progressive MS) are are asked about demographic Data, Anamnesis, pre-therapy and cli

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: age between 18 and 75 years. For patients additionally: Diagnosis of Multiple Sclerosis (McDonald-Criteria)

Exclusion criteria

Exclusion criteria: Clinical necessity for immune-suppressive or -modulator treatment for other reasons than MS. Other diseases or treatments, that influence cognitive functions. Pregnancy. MS-Escalation therapy.

Design outcomes

Primary

Measure	Time frame
The cerebral information processing capacity is measured with the neuropsychological testmethod "Ganzbericht" (Whole Report, based on the Theory of visual attention; TVA, Bundesen, 1990) at 3 points of time (Baseline 1. visit, 2. visit 1 year after 1. visit, 3. visit 1 year after 2. visit). It works as "Overall"-Parameter for cognitive performance and thus for cognitive decline in MS patients.	—

Secondary

Measure	Time frame
Neuropsychological Standard-Papertests measure cognitive performance as a comparison with the used TVA-Method (Word Fluency, Montreal Cognitive Assessment, Finding similarities, Mosaic-Test, Matrices-Test, general knowledge-Test). Further, cortical atrophy (with Morphometry) and cortical Degeneration (with iron residues) are measured with MRI. Additionally, frequent influences for cognitive performance of MS patients are measured with clinically established questionnaires (life quality questionnaire in short form SF-36, Modified Fatigue Impact Scale MFIS, Hospital Anxiety and Depression-Scale HAD-S, Pittsburgh Sleep Quality Index PSQI), the disability status is measured with established disability tests for MS (Expanded Disability Status Scale EDSS, Multiple Sclerosis Functional Composite MSFC). The MARS-Letter-Contrast-Sensitivity-Test is conducted to measure the contrast-perception. The MRI is measured at 2 points of time (Baseline 1. visit, 3. visit 2 years after 1. visit), all other Secondary Outcomes are measured at 3 points of time (Baseline 1. visit, 2. visit 1 year after 1. visit, 3. visit 1 year after 2. visit).	—

Measure

Time frame

Neuropsychological Standard-Papertests measure cognitive performance as a comparison with the used TVA-Method (Word Fluency, Montreal Cognitive Assessment, Finding similarities, Mosaic-Test, Matrices-Test, general knowledge-Test). Further, cortical atrophy (with Morphometry) and cortical Degeneration (with iron residues) are measured with MRI. Additionally, frequent influences for cognitive performance of MS patients are measured with clinically established questionnaires (life quality questionnaire in short form SF-36, Modified Fatigue Impact Scale MFIS, Hospital Anxiety and Depression-Scale HAD-S, Pittsburgh Sleep Quality Index PSQI), the disability status is measured with established disability tests for MS (Expanded Disability Status Scale EDSS, Multiple Sclerosis Functional Composite MSFC). The MARS-Letter-Contrast-Sensitivity-Test is conducted to measure the contrast-perception. The MRI is measured at 2 points of time (Baseline 1. visit, 3. visit 2 years after 1. visit), all other Secondary Outcomes are measured at 3 points of time (Baseline 1. visit, 2. visit 1 year after 1. visit, 3. visit 1 year after 2. visit).

—

Countries

Germany

Contacts

Public ContactSteffen Kluckow

Hans-Berger-Klinik für Neurologie, Universitätsklinikum Jena

steffen.kluckow@med.uni-jena.de03641 9396659

Outcome results

None listed

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