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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05017142
Other study ID # 2019-00377
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 14, 2020
Est. completion date January 1, 2071

Study information

Verified date March 2023
Source University of Bern
Contact Lorena F Hulliger, MSc
Phone 0316845678
Email lorena.hulliger@ispm.unibe.ch
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date January 1, 2071
Est. primary completion date January 1, 2071
Accepts healthy volunteers No
Gender All
Age group 0 Years and older
Eligibility Inclusion 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. - Written informed consent by patients (and/or legal representative(s), if applicable) - Optic Neuritis - Transverse Myelitis - Acute disseminated encephalomyelitis - Multiple Sclerosis - Neuromyelitis Optica Spectrum Disorders - Anti-NMDA-R 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 Encephalitis Exclusion Criteria: - Neurological symptoms due to infectious diseases of the CNS - Genetic/metabolic causes of central demyelinating diseases - Neurological symptoms due to Guillain-Barré-Syndrome

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Kantonsspital Aarau Aarau Aargau
Switzerland University Children's Hospital Basel, UKBB Basel
Switzerland Pediatric Institute of Southern Switzerland, Ospedale San Giovanni Bellinzona Ticino
Switzerland Institute of Social and Preventive Medicine, University of Bern Bern
Switzerland University Children's Hospital, Inselspital Bern Bern
Switzerland Kantonsspital Graubünden Chur Graubünden
Switzerland University Hospitals of Geneva (HUG) Geneva
Switzerland University Children's Hospital Lausanne (CHUV) Lausanne Vaud
Switzerland Luzerner Kantonsspital Luzern
Switzerland Children's Hospital of Eastern Switzerland St.Gallen Saint Gallen
Switzerland Kinderspital Winterthur Winterthur Zurich
Switzerland University Children's Hospital Zurich Zurich

Sponsors (5)

Lead Sponsor Collaborator
University of Bern Novartis, Roche Pharma (Switzerland) Ltd, Schweizerische Multiple Sklerose Gesellschaft, University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Personal data Registering patient's personal data At registration (Life-long; Up to 80 years)
Primary Diagnosis Diagnosis of IBrainD Until reaching of adulthood (0 to 18 years)
Primary Age at diagnosis Age at diagnosis (months and years) Until reaching of adulthood (0 to 18 years)
Primary First symptoms Symptoms before diagnosis Until reaching of adulthood (0 to 18 years)
Primary Age at first symptoms Age at first symptoms Until reaching of adulthood (0 to 18 years)
Primary Diagnostic delay Time elapsed between symptom-onset and diagnosis (days) Until reaching of adulthood (0 to 18 years)
Primary Hospitalization Length of hospitalization at diagnosis or during a relapse (days) Until reaching of adulthood (0 to 18 years)
Primary Rehabilitation Length and type of rehabilitation at diagnosis or during a relapse (days) Until reaching of adulthood (0 to 18 years)
Primary Death date Date of death Life-long; Up to 80 years
Primary Death cause Cause of death Life-long; Up to 80 years
Primary Change in EDSS EDSS change over time Until reaching of adulthood (0 to 18 years)
Primary Change in Neurostatus Neurostatus change over time Until reaching of adulthood (0 to 18 years)
Primary Change in medication Change of IBrainD medication over time Until reaching of adulthood (0 to 18 years)
Primary Change in Education Evolution of education over time Until reaching of adulthood (0 to 18 years)
Primary Change in MRI data Change in number of CNS lesions Until reaching of adulthood (0 to 18 years)
Primary Change in MRI data Change in activity of CNS lesions Until reaching of adulthood (0 to 18 years)
Primary Change in laboratory test data Change in diagnostic markers Until reaching of adulthood (0 to 18 years)
Primary Electrophysiological testing Assessment if the patient did undergo electrophysiological testing. Until reaching of adulthood (0 to 18 years)
Secondary Future questionnaires Data from validated instrument such as the Pediatric Quality of Life Inventory (PedsQL); Scale from 0-100, where 100 is the best possible outcome and 0 the worst possible outcome. Life-long; Up to 80 years; Will mainly concern childhood (until reaching of adulthood; 0 to 18 years)
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