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

NCT05017142 | Recruiting

• 1 other identifier: 2019-00377
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 13

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 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.

Conditions

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)

Outcome Measures

Primary Outcomes (18)

• Personal data

  Registering patient's personal data

  At registration (Life-long; Up to 80 years)

• Diagnosis

  Diagnosis of IBrainD

  Until reaching of adulthood (0 to 18 years)

• Age at diagnosis

  Age at diagnosis (months and years)

  Until reaching of adulthood (0 to 18 years)

• First symptoms

  Symptoms before diagnosis

  Until reaching of adulthood (0 to 18 years)

• Age at first symptoms

  Age at first symptoms

  Until reaching of adulthood (0 to 18 years)

• Diagnostic delay

  Time elapsed between symptom-onset and diagnosis (days)

  Until reaching of adulthood (0 to 18 years)

• Hospitalization

  Length of hospitalization at diagnosis or during a relapse (days)

  Until reaching of adulthood (0 to 18 years)

• Rehabilitation

  Length and type of rehabilitation at diagnosis or during a relapse (days)

  Until reaching of adulthood (0 to 18 years)

• Death date

  Date of death

  Life-long; Up to 80 years

• Death cause

  Cause of death

  Life-long; Up to 80 years

• Change in EDSS

  EDSS change over time

  Until reaching of adulthood (0 to 18 years)

• Change in Neurostatus

  Neurostatus change over time

  Until reaching of adulthood (0 to 18 years)

• Change in medication

  Change of IBrainD medication over time

  Until reaching of adulthood (0 to 18 years)

• Change in Education

  Evolution of education over time

  Until reaching of adulthood (0 to 18 years)

• Change in MRI data

  Change in number of CNS lesions

  Until reaching of adulthood (0 to 18 years)

• Change in MRI data

  Change in activity of CNS lesions

  Until reaching of adulthood (0 to 18 years)

• Change in laboratory test data

  Change in diagnostic markers

  Until reaching of adulthood (0 to 18 years)

• Electrophysiological testing

  Assessment if the patient did undergo electrophysiological testing.

  Until reaching of adulthood (0 to 18 years)

Secondary Outcomes (1)

• Future questionnaires

  Life-long; Up to 80 years; Will mainly concern childhood (until reaching of adulthood; 0 to 18 years)

Study Arms (1)

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

Eligibility Criteria

• Age: Up to 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Neurological symptoms due to infectious diseases of the CNS
• Genetic/metabolic causes of central demyelinating diseases
• Neurological symptoms due to Guillain-Barré-Syndrome

Sponsors & Collaborators

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

Study Sites (13)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

Children's Hospital of Eastern Switzerland

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

RECRUITING

University Children's Hospital Lausanne (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

RECRUITING

Pediatric Institute of Southern Switzerland, Ospedale San Giovanni

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

RECRUITING

University Children's Hospital Basel, UKBB

Basel, 4031, Switzerland

RECRUITING

University Children's Hospital, Inselspital Bern

Bern, 3010, Switzerland

RECRUITING

Institute of Social and Preventive Medicine, University of Bern

Bern, 3012, Switzerland

RECRUITING

Hôpital Fribourgeois - Freiburger Spital

Fribourg, 1752, Switzerland

NOT YET RECRUITING

University Hospitals of Geneva (HUG)

Geneva, 1211, Switzerland

RECRUITING

Kinderspital Zentralschweiz

Lucerne, 6000, Switzerland

RECRUITING

University Children's Hospital Zurich

Zurich, 8032, Switzerland

RECRUITING

Related Links

• Website of the registry

MeSH Terms

Conditions

Optic Neuritis; Myelitis, Transverse; Encephalomyelitis, Acute Disseminated; Multiple Sclerosis; Neuromyelitis Optica; Anti-N-Methyl-D-Aspartate Receptor Encephalitis; Autoimmune Diseases of the Nervous System; Vasculitis, Central Nervous System; Lupus Vasculitis, Central Nervous System; Encephalitis; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Demyelinating Autoimmune Diseases, CNS; Central Nervous System Diseases; Spinal Cord Diseases; Demyelinating Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Autoimmune Diseases; Immune System Diseases; Leukoencephalopathies; Brain Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Meningoencephalitis; Central Nervous System Viral Diseases; Meningitis; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sandra Bigi, PD MD

  ISPM, University of Bern, Bern; Kinderspital Zentralschweiz, Luzern

  PRINCIPAL INVESTIGATOR

• Sandra Bigi, PD MD

  ISPM, University of Bern, Bern Kinderspital Zentralschweiz, Luzern

  STUDY DIRECTOR

Central Study Contacts

Lorena F Hulliger, MSc

CONTACT

+41316845678; lorena.hulliger@unibe.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 18 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 23, 2021
• Study Start: April 14, 2020
• Primary Completion (Estimated): January 1, 2071
• Study Completion (Estimated): January 1, 2071
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

CH (13)