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

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2014
INTERVENTION: Intervention 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 clinical Parameters like disease duration, ‐activity, course and ‐therapy by the study physician. Separately, standardized tests measure the disability status (EDSS, MSFC), cerebral Information processing capacity (with TVA‐Method "Ganzbericht", Whole Report), Quality of Life, Fatigue, Depression, Cytokine state (in blood), sleep behaviour, cognitive performance with neuropsychological Standard‐Tests, executive functions and contrast‐sensitivity for 3 times in 2 years. The period of investigation refers to the past 4 weeks. The study physician/assistence is blinded regarding to the results of the patients data. The MRI is only measured after the 1. visit and after 2 years again. Intervention 2: The 210 MS patients in total are compared with 70 age‐, education‐ and sex‐matched healthy controls that are likewise asked about demographic Data, Anamnesis and other diseases by the study physician. Separately, standardized tests measure the disability status (EDSS, MSFC), cerebral Information processing capacity (with TVA‐Method "Ganzbericht", Whole Report), Quality of Life, Fatigue, Depression, Cytokine state (in blood), sleep behaviour, cognitive performance with neuropsychological Standard‐Tests, executive functions and contrast‐sensitivity for 3 times in 2 years. The period of investigation refers to the past 4 weeks. The study physician/assistence is blinded regarding to the results of the healthy controls data. The MRI is only measured after the 1. visit and after 2 years again. CONDITION: G35 ‐ Multiple sclerosis PRIMARY OUTCOME: 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. INCLUSION CRITERIA: age between 18 and 75 years. For patients additionally: Diagnosis of Multiple Sclerosis (McDonald‐Criteria) SECONDARY OUTCOME: 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).
Epistemonikos ID: b1e62edf96a5328bf2f88d4947ef7ee3bc9724e9
First added on: Mar 31, 2022