Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)

Brief Title

Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)

Official Title

Swiss Pediatric Inflammatory Bain Disease Cohort Study

Brief 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.

Detailed Description


      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.


      The registry pursues the following goals:

        1. Gathering representative, population-based epidemiological data on pediatric IBrainD in

        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.


        -  Schweizerische Multiple Sklerose Gesellschaft

        -  PedNet Bern

        -  Roche Pharma (Switzerland) Ltd

        -  Novartis Pharma Schweiz AG

        -  SwissPedRegistry, University of Bern

Study Type

Observational [Patient Registry]

Primary Outcome

Personal data

Secondary Outcome

 Future questionnaires


Optic Neuritis

Study Arms / Comparison Groups

 Patient population
Description:  Children, adolescents and adults diagnosed with an IBrainD before age 18, who are born, treated or living in Switzerland


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

April 14, 2020

Completion Date

January 1, 2071

Primary Completion Date

January 1, 2071

Eligibility Criteria

        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




N/A - N/A

Accepts Healthy Volunteers



Sandra Bigi, PD MD, 0316845678, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

University of Bern


 Schweizerische Multiple Sklerose Gesellschaft

Study Sponsor

Sandra Bigi, PD MD, Principal Investigator, ISPM, University of Bern, Bern; University Children's Hospital, University of Bern, Bern

Verification Date

August 2021