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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages N/A - 36 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05017142
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Bern
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sandra Bigi, PD MDSandra Bigi, PD MD
Principal Investigator Affiliation ISPM, University of Bern, Bern; Kinderspital Zentralschweiz, LuzernISPM, University of Bern, Bern Kinderspital Zentralschweiz, Luzern
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Optic Neuritis, Transverse Myelitis, Acute Disseminated Encephalomyelitis, Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder, Anti-NMDAR 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 Encephalitis, CNS Vasculitis, CNS Sarcoidosis, CNS Lupus, Rasmussen Encephalitis, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Study Website: View Trial Website
Additional Details

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 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: 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, 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

Arms & Interventions

Arms

: Patient population

Children, adolescents and adults diagnosed with an IBrainD from 2005 onward and with disease onset before age 18, who are born, treated or living in Switzerland

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kantonsspital Aarau, Aarau, Aargau, Switzerland

Status

Recruiting

Address

Kantonsspital Aarau

Aarau, Aargau, 5001

Site Contact

Esmeralda Nava, Dr. med.

[email protected]

+41316845678

Kantonsspital Graubünden, Chur, Graubünden, Switzerland

Status

Recruiting

Address

Kantonsspital Graubünden

Chur, Graubünden, 7000

Site Contact

Susi Strozzi, Dr. med.

[email protected]

+41316845678

St.Gallen, Saint Gallen, Switzerland

Status

Recruiting

Address

Children's Hospital of Eastern Switzerland

St.Gallen, Saint Gallen, 9000

Site Contact

Oliver Maier, Dr. med.

[email protected]

+41316845678

Bellinzona, Ticino, Switzerland

Status

Recruiting

Address

Pediatric Institute of Southern Switzerland, Ospedale San Giovanni

Bellinzona, Ticino, 6500

Site Contact

Barbara Goeggel Simonetti, PD Dr. med.

[email protected]

+41316845678

Lausanne, Vaud, Switzerland

Status

Recruiting

Address

University Children's Hospital Lausanne (CHUV)

Lausanne, Vaud, 1011

Site Contact

Stéphane Darteyre

[email protected]

+41316845678

Kantonsspital Winterthur, Winterthur, Zurich, Switzerland

Status

Recruiting

Address

Kantonsspital Winterthur

Winterthur, Zurich, 8400

Site Contact

Florian Bauder, Dr. med.

[email protected]

+41316845678

Basel, Switzerland

Status

Recruiting

Address

University Children's Hospital Basel, UKBB

Basel, , 4031

Site Contact

Patricia Dill, Dr. med.

[email protected]

+41316845678

Bern, Switzerland

Status

Recruiting

Address

University Children's Hospital, Inselspital Bern

Bern, , 3010

Site Contact

Gabriela Oesch Nemeth, Dr. med.

[email protected]

+41316845678

Bern, Switzerland

Status

Recruiting

Address

Institute of Social and Preventive Medicine, University of Bern

Bern, , 3012

Site Contact

Lorena F Hulliger

[email protected]

+41316845678

Hôpital Fribourgeois - Freiburger Spital, Fribourg, Switzerland

Status

Not yet recruiting

Address

Hôpital Fribourgeois - Freiburger Spital

Fribourg, , 1752

Site Contact

Mary Kurian, Dr. med.

[email protected]

+41316845678

University Hospitals of Geneva (HUG), Geneva, Switzerland

Status

Recruiting

Address

University Hospitals of Geneva (HUG)

Geneva, , 1211

Site Contact

Stéphanie Garcia-Tarodo, Dr. med.

[email protected]

+41316845678

Kinderspital Zentralschweiz, Luzern, Switzerland

Status

Recruiting

Address

Kinderspital Zentralschweiz

Luzern, , 6000

Site Contact

Sandra Bigi

[email protected]

+41316845678

University Children's Hospital Zurich, Zurich, Switzerland

Status

Recruiting

Address

University Children's Hospital Zurich

Zurich, , 8032

Site Contact

Annette Hackenberg, Dr. med.

[email protected]

+41316845678

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