Optic NeuritisNCT05017142
Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)
An observational study of Optic Neuritis and Transverse Myelitis, run by University of Bern at 13 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 36 years
- Conditions the study is for
- Optic Neuritis, Transverse Myelitis, Acute Disseminated Encephalomyelitis
- How many people
- 500 participants
- Where
- 13 sitesSwitzerland
- Study dates
- 14 Apr 2020to 1 Jan 2071
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- Neurological symptoms due to infectious diseases of the CNS
- Genetic/metabolic causes of central demyelinating diseases
- Neurological symptoms due to Guillain-Barré-Syndrome
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Switzerland13 sites, 13 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001
Esmeralda Nava, Dr. med.
- Recruiting
University Children's Hospital Basel, UKBB
Basel, 4031
Patricia Dill, Dr. med.
- Recruiting
Pediatric Institute of Southern Switzerland, Ospedale San Giovanni
Bellinzona, Canton Ticino, 6500
Barbara Goeggel Simonetti, PD Dr. med.
- Recruiting
University Children's Hospital, Inselspital Bern
Bern, 3010
Gabriela Oesch Nemeth, Dr. med.
- Recruiting
Institute of Social and Preventive Medicine, University of Bern
Bern, 3012
Lorena F Hulliger, +41316845678, lorena.hulliger@unibe.ch
- Recruiting
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
Susi Strozzi, Dr. med.
- Not yet recruiting
Hôpital Fribourgeois - Freiburger Spital
Fribourg, 1752
Mary Kurian, Dr. med.
- Recruiting
University Hospitals of Geneva (HUG)
Geneva, 1211
Stéphanie Garcia-Tarodo, Dr. med.
- Recruiting
University Children's Hospital Lausanne (CHUV)
Lausanne, Canton of Vaud, 1011
Stéphane Darteyre
- Recruiting
Kinderspital Zentralschweiz
Lucerne, 6000
Sandra Bigi
- Recruiting
Children's Hospital of Eastern Switzerland
Sankt Gallen, Canton of St. Gallen, 9000
Oliver Maier, Dr. med.
Ingrid Beck
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8400
Florian Bauder, Dr. med.
- Recruiting
University Children's Hospital Zurich
Zurich, 8032
Annette Hackenberg, Dr. med.
About this study
Official title: Swiss Pediatric Inflammatory Bain Disease Cohort Study
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.
Read the detailed description
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
- Conditions
- Optic Neuritis, Transverse Myelitis, Acute Disseminated Encephalomyelitis, Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder, Anti-NMDAR Encephalitis
- Medical subject headings
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal data
Registering patient's personal data
Measured: At registration (Life-long; Up to 80 years)
Diagnosis
Diagnosis of IBrainD
Measured: Until reaching of adulthood (0 to 18 years)
Age at diagnosis
Age at diagnosis (months and years)
Measured: Until reaching of adulthood (0 to 18 years)
First symptoms
Symptoms before diagnosis
Measured: Until reaching of adulthood (0 to 18 years)
Age at first symptoms
Age at first symptoms
Measured: Until reaching of adulthood (0 to 18 years)
Diagnostic delay
Time elapsed between symptom-onset and diagnosis (days)
Measured: Until reaching of adulthood (0 to 18 years)
Hospitalization
Length of hospitalization at diagnosis or during a relapse (days)
Measured: Until reaching of adulthood (0 to 18 years)
Rehabilitation
Length and type of rehabilitation at diagnosis or during a relapse (days)
Measured: Until reaching of adulthood (0 to 18 years)
Death date
Date of death
Measured: Life-long; Up to 80 years
Death cause
Cause of death
Measured: Life-long; Up to 80 years
Change in EDSS
EDSS change over time
Measured: Until reaching of adulthood (0 to 18 years)
Change in Neurostatus
Neurostatus change over time
Measured: Until reaching of adulthood (0 to 18 years)
Change in medication
Change of IBrainD medication over time
Measured: Until reaching of adulthood (0 to 18 years)
Change in Education
Evolution of education over time
Measured: Until reaching of adulthood (0 to 18 years)
Change in MRI data
Change in number of CNS lesions
Measured: Until reaching of adulthood (0 to 18 years)
Change in MRI data
Change in activity of CNS lesions
Measured: Until reaching of adulthood (0 to 18 years)
Change in laboratory test data
Change in diagnostic markers
Measured: Until reaching of adulthood (0 to 18 years)
Electrophysiological testing
Assessment if the patient did undergo electrophysiological testing.
Measured: Until reaching of adulthood (0 to 18 years)
Secondary outcomes (1)
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.
Measured: Life-long; Up to 80 years; Will mainly concern childhood (until reaching of adulthood; 0 to 18 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start14 Apr 2020
- Primary completion1 Jan 2071 (estimated)
- Study completion1 Jan 2071 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Sandra Bigi, PD MD, Principal investigator, ISPM, University of Bern, Bern; Kinderspital Zentralschweiz, LuzernSandra Bigi, PD MD, Study director, ISPM, University of Bern, Bern Kinderspital Zentralschweiz, Luzern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017142
- Sponsor's protocol ID
- 2019-00377
- Other IDs
- 2019
- Status last verified
- Dec 2024
- First submitted
- 4 Aug 2021
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Pediatric Inflammatory Bain Disease Cohort Study
- ClinicalTrials.gov ID
- NCT05017142
- Acronym / sponsor ID
- 2019-00377
- Conditions
- Optic Neuritis, Transverse Myelitis, Acute Disseminated Encephalomyelitis, Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder, Anti-NMDAR Encephalitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- 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
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 1 Jan 2071 (estimated)
- Study completion
- 1 Jan 2071 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 18 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (3 listed)
- Neurological symptoms due to infectious diseases of the CNS
- Genetic/metabolic causes of central demyelinating diseases
- Neurological symptoms due to Guillain-Barré-Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Personal data
Time frame: At registration (Life-long; Up to 80 years)
Registering patient's personal data
Diagnosis
Time frame: Until reaching of adulthood (0 to 18 years)
Diagnosis of IBrainD
Age at diagnosis
Time frame: Until reaching of adulthood (0 to 18 years)
Age at diagnosis (months and years)
First symptoms
Time frame: Until reaching of adulthood (0 to 18 years)
Symptoms before diagnosis
Age at first symptoms
Time frame: Until reaching of adulthood (0 to 18 years)
Age at first symptoms
Diagnostic delay
Time frame: Until reaching of adulthood (0 to 18 years)
Time elapsed between symptom-onset and diagnosis (days)
Hospitalization
Time frame: Until reaching of adulthood (0 to 18 years)
Length of hospitalization at diagnosis or during a relapse (days)
Rehabilitation
Time frame: Until reaching of adulthood (0 to 18 years)
Length and type of rehabilitation at diagnosis or during a relapse (days)
Death date
Time frame: Life-long; Up to 80 years
Date of death
Death cause
Time frame: Life-long; Up to 80 years
Cause of death
Change in EDSS
Time frame: Until reaching of adulthood (0 to 18 years)
EDSS change over time
Change in Neurostatus
Time frame: Until reaching of adulthood (0 to 18 years)
Neurostatus change over time
Change in medication
Time frame: Until reaching of adulthood (0 to 18 years)
Change of IBrainD medication over time
Change in Education
Time frame: Until reaching of adulthood (0 to 18 years)
Evolution of education over time
Change in MRI data
Time frame: Until reaching of adulthood (0 to 18 years)
Change in number of CNS lesions
Change in MRI data
Time frame: Until reaching of adulthood (0 to 18 years)
Change in activity of CNS lesions
Change in laboratory test data
Time frame: Until reaching of adulthood (0 to 18 years)
Change in diagnostic markers
Electrophysiological testing
Time frame: Until reaching of adulthood (0 to 18 years)
Assessment if the patient did undergo electrophysiological testing.
1 secondary outcome
Future questionnaires
Time frame: Life-long; Up to 80 years; Will mainly concern childhood (until reaching of adulthood; 0 to 18 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Website of the registryLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra Bigi, PD MD principal investigator
ISPM, University of Bern, Bern; Kinderspital Zentralschweiz, Luzern
Sandra Bigi, PD MD study director
ISPM, University of Bern, Bern Kinderspital Zentralschweiz, Luzern
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Neuritis and Transverse Myelitis, run by University of Bern at 13 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorena F Hulliger, MSc (+41316845678, lorena.hulliger@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal data (time frame: At registration (Life-long; Up to 80 years)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.