Registry and biobank for neuroimmunological diseases
Registry for Patients With Antibody-mediated Neuroimmunological Diseases
This study is trying to see if certain antibodies in the brain are linked to neurological disorders like encephalopathy and psychosis, and how they might affect patients' health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 2 sites (Berlin, State of Berlin and 1 other locations) |
| Trial ID | NCT06958341 on ClinicalTrials.gov |
What this trial studies
This registry aims to investigate the prevalence and significance of antineuronal antibodies in patients with various neurological disorders, including encephalopathy and psychosis. It will collect cerebrospinal fluid (CSF) samples and clinical data to explore correlations between these antibodies and conditions like HSV infection and NMDA receptor autoimmunity. The study seeks to determine whether these antibodies are disease-specific or merely a result of inflammation, and to assess the clinical outcomes of patients with these antibodies. By establishing a comprehensive database, the research hopes to enhance understanding of autoimmune encephalitis and related disorders.
Who should consider this trial
Good fit: Ideal candidates include individuals suspected of having neuroimmunological diseases who require a lumbar puncture for diagnosis.
Not a fit: Patients who do not have a suspected neuroimmunological condition or those who withdraw consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved diagnosis and treatment options for patients with autoimmune neurological diseases.
How similar studies have performed: Other studies have shown promise in understanding autoimmune encephalitis, but this registry approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Differential diagnosis: suspected neuroimmunological disease in which a lumbar puncture is indicated for further diagnosis and treatment decision 2. Individuals with unclear clinical diagnosis where additional CSF is to be collected for isolation of B cells and production of monoclonal antibodies. The clinical condition of the patients and his/her compliance have to allow an extra 2-3 ml of CSF to be collected. 3. Age: all age groups 4. Gender: patients of both sexes will be included Exclusion criteria: \[1\] Withdrawal of consent
Where this trial is running
Berlin, State of Berlin and 1 other locations
- Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Recruiting)
- Universität Ulm — Ulm, Germany (Recruiting)
Study contacts
- Principal investigator: Marc Nikolaus, MD — Charite - Universitaetsmedizin Berlin
- Study coordinator: Markus Schuelke, MD
- Email: markus.schuelke@charite.de
- Phone: +49 30 450 566112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.