An observational study in Optic Neuritis, Transverse Myelitis and Acute Disseminated Encephalomyelitis, sponsored by University of Bern. Recruiting at 13 sites in Switzerland. Open to participants aged Up to 36 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by University of Bern · Observational
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.
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:
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.
Excluded are patients with:
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:
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:
178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.
This study's planned enrollment of 500 is above the median of 200 across 62 observational studies indexed under Neuromyelitis Optica.
Browse Neuromyelitis Optica studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
Compared within Neuromyelitis Optica, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Optic Neuritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All patients living and/or treated in Switzerland with a listed IBrainD diagnosed from 2005 onward and a disease onset before the age of 18.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Personal data
Registering patient's personal data
Time frame: At registration (Life-long; Up to 80 years)
Diagnosis
Diagnosis of IBrainD
Time frame: Until reaching of adulthood (0 to 18 years)
Age at diagnosis
Age at diagnosis (months and years)
Time frame: Until reaching of adulthood (0 to 18 years)
First symptoms
Symptoms before diagnosis
Time frame: Until reaching of adulthood (0 to 18 years)
Age at first symptoms
Age at first symptoms
Time frame: Until reaching of adulthood (0 to 18 years)
Diagnostic delay
Time elapsed between symptom-onset and diagnosis (days)
Time frame: Until reaching of adulthood (0 to 18 years)
Hospitalization
Length of hospitalization at diagnosis or during a relapse (days)
Time frame: Until reaching of adulthood (0 to 18 years)
Rehabilitation
Length and type of rehabilitation at diagnosis or during a relapse (days)
Time frame: Until reaching of adulthood (0 to 18 years)
Death date
Date of death
Time frame: Life-long; Up to 80 years
Death cause
Cause of death
Time frame: Life-long; Up to 80 years
Change in EDSS
EDSS change over time
Time frame: Until reaching of adulthood (0 to 18 years)
Change in Neurostatus
Neurostatus change over time
Time frame: Until reaching of adulthood (0 to 18 years)
Change in medication
Change of IBrainD medication over time
Time frame: Until reaching of adulthood (0 to 18 years)
Change in Education
Evolution of education over time
Time frame: Until reaching of adulthood (0 to 18 years)
Change in MRI data
Change in number of CNS lesions
Time frame: Until reaching of adulthood (0 to 18 years)
Change in MRI data
Change in activity of CNS lesions
Time frame: Until reaching of adulthood (0 to 18 years)
Change in laboratory test data
Change in diagnostic markers
Time frame: Until reaching of adulthood (0 to 18 years)
Electrophysiological testing
Assessment if the patient did undergo electrophysiological testing.
Time frame: Until reaching of adulthood (0 to 18 years)
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.
Time frame: Life-long; Up to 80 years; Will mainly concern childhood (until reaching of adulthood; 0 to 18 years)
Plan to share: Yes — Researchers who wish to develop a nested study need to submit a proposal to the Swiss-Ped-IBrainD committee and request permission. A concept sheet describing the planned analyses must be approved by the Swiss-Ped-IBrainD committee. Nested studies might need separate ethics permission.
Started Apr 2020 (actual). Primary completion is estimated for Jan 2071, 608 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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