G61.8 G61.0
Conditions
Interventions
Group 1: All participating patients are examined at baseline, after 6 months, then annually, and biomaterial samples are stored. If necessary, interim visits can be added for the same purpose.
Sponsors
Ruhr-Universität Bochum St. Josef-Hospital Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with a suspected or confirmed diagnosis of immune neuropathy are included. These include all autoimmune neuropathies (acute inflammatory polyneuropathy = GBS; chronic inflammatory neuropathies = CIN / type of CIDP), as well as all paraneoplastic neuropathies, vasculitic neuropathies, paraproteinemic neuropathies and pathogen-mediated neuropathies as well as accompanying neuropathies in systemic neuropathies. Diabetic polyneuropathy is a special form of immune neuropathy and is also part of the study group. The exact mechanism of critical illness polyneuropathy has not yet been clarified, but there are indications of an immunological cause, so that these patients are also included.
Exclusion criteria
Exclusion criteria: Patients who • do not give consent to participate in the study • are unable to provide information themselves or through an authorized representative or have serious psychiatric illnesses • In the case of contraindications for individual follow-up examinations such as neurography, QST, corneal microscopy or skin biopsy, the respective examination will not be performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary goal of this project is to establish a longitudinal prospective cohort with patients with autoimmune neuropathies (AIN) to characterize the broad spectrum of the disease. For this purpose, a project-related biobank is being set up which, in addition to clinical data and instrumental examinations, records blood, urine, liquor, and plasmapheresis samples as well as histological samples from skin and nerve biopsies. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Furthermore, in the future, our results should be linked to other registers if necessary and samples and data should be available for further national and international research projects in double pseudonymised form. 3. The results of studies in this register are intended to help validate and anchor sensible and necessary clinical and instrument-based diagnostics (HRUS, CCM, structured QL-Assessment) for diagnosis and progression diagnosis of AIN as an integral part of national and international guidelines. 4. With the help of future results from this study, the aim is to contribute to the validation of known and identification of new biomarkers, mostly autoantibodies (AAB) against surface or intracellular proteins. If new AABs are identified, the specificity and sensitivity of these AABs will be further characterized by examining voluntary non-AIN patients / donors. Another aim is to investigate the pathomechanisms of identified AABs through functional studies in suitable cell culture and animal models. A long-term goal should also be to contribute to the role of genetic influencing factors in AIN. However, these are not direct goals that can be derived from this study protocol, but only give an outlook on future separate studies and experiments. The interdisciplinary working group with all participating clinics of the INHIBIT registry aims to form a cohort in an unlimited number of patients with possible immune-mediated neuropathy (estimated 500 cases in 5 years) and healthy controls or different diseases without evidence of immune-mediated neuropathies. The control group is included with the same protocol using a clinical apparatus-based neuro-assessment, with the simultaneous use of all the instruments described, also through the determination of relevant possible biomarkers in serum, skin and other tissues, and through examinations of genetic risk factors. | — |
Countries
Germany
Contacts
Public ContactAnna Lena Fisse
Ruhr-Universität Bochum St. Josef-Hospital Klinik für Neurologie
Outcome results
None listed