ClinicalTrials.gov record NCT05017142

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Swiss Pediatric Inflammatory Bain Disease Cohort Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
AgeUp to 36 years old
SexAll
LocationSwitzerland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This national registry collects medical information on people (children, adolescents, and people) whose inflammatory brain disease began before age 18 and were diagnosed from 2005 onward. Data come from medical records, treating clinicians, and questionnaires from patients and families; no extra examinations are required for the registry. The registry documents diagnosis, symptoms, treatments, hospital stays, rehabilitation, education and long-term outcomes to support research and clinical knowledge exchange.

What it is studying. The registry is gathering representative data to describe how pediatric inflammatory brain diseases present, are diagnosed and treated, and how patients do over time (clinical course, education and social outcomes). It also aims to track diagnostic delays, hospital and rehabilitation use, and longer-term outcomes.

What the researchers hope to learn. To produce population-based epidemiological data on pediatric inflammatory brain diseases in Switzerland; to monitor diagnostic workup, treatments, clinical course, education and social outcomes; to create a platform that facilitates national and international research collaboration and exchange of knowledge between clinicians and researchers.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 opened for recruitment after that: Aarau, Basel, Bellinzona, Chur, Geneva, Lausanne, Lucerne, St. Gallen, Winterthur and Zurich. The center in Fribourg is expected open for recruitment in 2025. 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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • All patients living and/or treated in Switzerland with an IBrainD specified in the following list diagnosed from 2005 onward and 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
  • Myelin oligodendrocyte glycoprotein antibody-associated disease
  • 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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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:

  • Gathering representative, population-based epidemiological data on pediatric IBrainD in Switzerland.
  • Monitoring treatment, clinical course, education, social aspects, and outcomes of pediatric IBrainD patients.
  • 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 diagnosed from 2005 onward and with a disease onset before the age of 18.

  • Optic neuritis
  • Transverse myelitis
  • Acute disseminated encephalomyelitis
  • Multiple sclerosis
  • Neuromyelitis optica spectrum disorders
  • Myelin oligodendrocyte glycoprotein antibody-associated disease
  • 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:

  • Neurological symptoms due to infectious diseases of the CNS
  • Genetic/metabolic causes of central demyelinating diseases
  • 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, their 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: Since 2020, the investigators have included 128 people diagnosed with an IBrainD. Funding:

  • Schweizerische Multiple Sklerose Gesellschaft
  • PedNet Bern
  • SwissPedRegistry, University of Bern
  • Roche Pharma (Switzerland) Ltd
  • Novartis Pharma Schweiz AG
  • Biogen
  • Sanofi
  • Anna Mueller Grocholski-Stiftung
  • Gottfried und Julia Bangerter-Rhyner Stiftung
  • Fondation Johanna Dürmüller-Bol
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join, you (or your child) give informed consent and the study team will enter personal and medical information into the registry. The registry collects data from medical records and reports, from treating physicians, and from patients/families, and participants may be asked to complete questionnaires about health and quality of life (for example the PedsQL). No extra medical examinations are carried out specifically for the registry; diagnosis, treatment, and any tests ordered by the treating team continue as usual. Data may also be linked with routine statistics and other registries and will be recorded at registration and during follow‑up as described in the study record.

How the study is structured. An observational cohort registry. When a patient consents, their routine medical records and information from doctors, patients, and families are entered into the registry. The study collects baseline and follow-up data (including questionnaires) related to diagnosis, treatment, relapses, hospital stays, rehabilitation, imaging and laboratory results. No study-specific exams are performed; some outcomes are followed until adulthood and certain data can be kept life‑long (up to 80 years as specified).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Switzerland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Apr 14, 2020
Primary completion
Jan 1, 2071 (estimated)
Study completion
Jan 1, 2071 (estimated)
Target enrollment
500 participants (estimated)
Last updated on registry
Dec 16, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Bern
Collaborators
  • Schweizerische Multiple Sklerose Gesellschaft
  • Insel Gruppe AG, University Hospital Bern
  • Novartis
  • Anna Mueller Grocholski-Stiftung
  • Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
  • Biogen
  • Roche Pharma (Switzerland) Ltd
  • Fondation Johanna Dürmüller-Bol
  • Kantonsspital Aarau
  • University Children's Hospital Basel
  • Ente Ospedaliero Cantonale, Bellinzona
  • Kantonsspital Graubünden
  • University Hospital, Geneva
  • Centre Hospitalier Universitaire Vaudois
  • Ostschweizer Kinderspital
  • Kantonsspital Winterthur KSW
  • Sanofi
  • Hôpital Fribourgeois
  • University Children's Hospital, Zurich
  • Luzerner Kantonsspital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (13)

  • Kantonsspital AarauRecruiting

    Aarau, Canton of Aargau, 5001 · Switzerland

    • Esmeralda Nava, Dr. med.
  • Children's Hospital of Eastern SwitzerlandRecruiting

    Sankt Gallen, Canton of St. Gallen, 9000 · Switzerland

    • Oliver Maier, Dr. med.
    • Ingrid Beck
  • University Children's Hospital Lausanne (CHUV)Recruiting

    Lausanne, Canton of Vaud, 1011 · Switzerland

    • Stéphane Darteyre
  • Kantonsspital WinterthurRecruiting

    Winterthur, Canton of Zurich, 8400 · Switzerland

    • Florian Bauder, Dr. med.
  • Pediatric Institute of Southern Switzerland, Ospedale San GiovanniRecruiting

    Bellinzona, Canton Ticino, 6500 · Switzerland

    • Barbara Goeggel Simonetti, PD Dr. med.
  • Kantonsspital GraubündenRecruiting

    Chur, Kanton Graubünden, 7000 · Switzerland

    • Susi Strozzi, Dr. med.
  • University Children's Hospital Basel, UKBBRecruiting

    Basel, 4031 · Switzerland

    • Patricia Dill, Dr. med.
  • University Children's Hospital, Inselspital BernRecruiting

    Bern, 3010 · Switzerland

    • Gabriela Oesch Nemeth, Dr. med.
  • Institute of Social and Preventive Medicine, University of BernRecruiting

    Bern, 3012 · Switzerland

  • Hôpital Fribourgeois - Freiburger SpitalNot Yet Recruiting

    Fribourg, 1752 · Switzerland

    • Mary Kurian, Dr. med.

Terms used on this page · explanations by MedicalUpdates.ai

patient registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
legal representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Cohort Study
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
relapse
A condition that improved with treatment and has since returned or worsened.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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