Clinical Trials Logo

Clinical Trial Summary

The Swiss-Ped-IBrainD is a national patient registry that collects information on diagnosis, symptoms, treatment, and follow-up of pediatric patients with an inflammatory brain disease in Switzerland. It was first implemented in 2020 in the pediatric clinic of the university hospital in Bern. Further centers all over Switzerland were opened for recruitment in 2021; Aarau, Basel, Bellinzona, Chur, Geneva, Lausanne, Lucerne, St. Gallen, and Zurich. The center in Winterthur is expected to be open for recruitment by autumn 2021. The registry provides data for national and international monitoring and research. It supports research on inflammatory brain diseases in Switzerland and the exchange of knowledge between clinicians, researchers, and therapists. The registry aims to improve the treatment of children with inflammatory brain diseases and optimizing their health care and quality of life.


Clinical Trial Description

Background: Pediatric onset MS and other inflammatory brain diseases (IBrainDs) are severe diseases affecting children and adolescents in a period of essential brain development. This possibly leads to a variety of focal neurological deficits as well as early cognitive impairment. In turn, the cognitive impairment may impact school performance and vocational achievements. Timely diagnosis and treatment initiation as well as individually tailored management are important for a favorable disease course. However, the diagnosis of the different IBrainDs can be challenging, especially in young children, since their first acute inflammation is often accompanied by unspecific symptoms common to all IBrainDs. A systematic assessment of similarities and differences between clinical signs, symptoms, and diagnostic workup of different IBrainDs will enable faster and more reliable diagnosis. Furthermore, neither epidemiological data nor information on health care management and disease outcome of pediatric IBrainD patients exist in Switzerland. Therefore, a national registry is being established, which will allow a deeper understanding of pediatric IBrainD epidemiology, clinical presentation, and management. Ultimately, the registry will improve the care of children suffering from an IBrainD in Switzerland. The Swiss-Ped-IBrainD Registry (title: "Swiss Pediatric Inflammatory Brain Disease Cohort Study", project number: 2019-00377) has been approved by the ethics committees of Bern, the Ethikkommission Nordwest- und Zentralschweiz (EKNZ), the Ethikkommission Ostschweiz (EKOS), and the ethics committees of Zürich, Lausanne, Geneva, and Bellinzona. Objectives: The registry pursues the following goals: 1. Gathering representative, population-based epidemiological data on pediatric IBrainD in Switzerland. 2. Monitoring treatment, clinical course, education, social aspects, and outcomes of pediatric IBrainD patients. 3. Providing a platform to facilitate research, national and international collaboration and exchange of knowledge between experts. The registry thus addresses the increasing requests for medical trial participation and promotes the exchange with existing adult registries (e.g., Swiss MS Registry). Inclusion/exclusion criteria: All patients living and/or treated in Switzerland with an IBrainD specified in the following list with a disease onset before the age of 18. - Optic neuritis - Transverse myelitis - Acute disseminated encephalomyelitis - Multiple sclerosis - Neuromyelitis optica spectrum disorders - Anti-NMDA-R associated autoimmune encephalitis - Anti-GAD65 associated autoimmune encephalitis - Anti-AMPAR-1/2 associated autoimmune encephalitis - Anti-Lgi-1 associated autoimmune encephalitis - Anti-CASPR-2 associated autoimmune encephalitis - Anti-GABAR-1/2 associated autoimmune encephalitis - Onconeuronal antibody (Hu, Ri, Yo, Amphiphysin, CRMP-5, Ma-1, Ma-2, SOX-1) associated autoimmune encephalitis - Hashimoto encephalopathy - CNS vasculitis - CNS sarcoidosis - CNS Lupus - Rasmussen's encephalitis Excluded are patients with: 1. Neurological symptoms due to infectious diseases of the CNS 2. Genetic/metabolic causes of central demyelinating diseases 3. Neurological symptoms due to Guillain-Barré-Syndrome Registration of Patients and Collection of Medical Data: Pediatricians, pediatric neurologists, neurologists, specialists in rehabilitation, and primary care physicians at the participating centers are responsible to identify children with the listed IBrainDs during regular medical consultations. Upon identification, treating physicians inform patients and their parents orally and in writing about the Swiss-Ped-IBrainD. Patients (and their legal representatives if applicable) who want to participate must give their informed consent. Once a patient consents to participate, his/her medical data will be entered in the registry. The diagnostic workup and treatment of patients continue as usual and are independent from participation; no examination will be carried out specifically for the Swiss-Ped-IBrainD. Medical data is collected through the following sources: - Medical records and reports - Oral/written information from treating physician - Oral/written information from patient/family - Routine statistics and other medical registries - Questionnaires for patients and families The data collection focuses on diagnostic, follow-up, and relapse variables. Routine data and linkages: Communities; Federal Statistical Office (e.g. the birth register, cause of death statistics, hospital statistics) Current status: From 2020-2021, the investigators have included 17 persons diagnosed with an IBrainD. Funding: - Schweizerische Multiple Sklerose Gesellschaft - PedNet Bern - Roche Pharma (Switzerland) Ltd - Novartis Pharma Schweiz AG - SwissPedRegistry, University of Bern ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05017142
Study type Observational [Patient Registry]
Source University of Bern
Contact Lorena F Hulliger, MSc
Phone 0316845678
Email lorena.hulliger@ispm.unibe.ch
Status Recruiting
Phase
Start date April 14, 2020
Completion date January 1, 2071

See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT02845635 - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis