Actively Recruiting
Study of Pathogenic Mechanisms and Identification of Novel Autoantibodies in Autoimmune Encephalitis Through the Integration of Conventional Methodologies and Advanced Single-cell Technologies
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-03-17
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Autoimmune encephalitis is a serious brain disorder caused by inflammation that leads to rapid brain dysfunction, usually developing in less than six weeks. This condition includes several types, such as paraneoplastic syndromes where the immune system attacks the brain in response to a tumor, and autoimmune encephalitis where antibodies directly target brain proteins. Some cases do not have identified antibodies, such as seronegative autoimmune encephalitis and Susac syndrome, which affects the brain, retina, and inner ear. Researchers aim to better understand the disease and discover new antibodies that may explain currently undiagnosed cases. This research is an observational study involving patients diagnosed with autoimmune encephalitis linked to specific antibodies and those with seronegative forms or Susac syndrome. A control group includes patients with other neurological disorders who do not have these antibodies. The study involves collecting and analyzing blood and spinal fluid samples to identify antibodies and generate recombinant monoclonal antibodies from patients' B cells. The study integrates conventional and advanced single-cell technologies to explore disease mechanisms. Participants will provide informed consent and undergo sample collection for antibody detection and analysis. Researchers will isolate polyclonal IgG from serum and create human recombinant antibodies over time. The study measures the ability to generate antibodies specific to target antigens as the primary outcome within 12 months. Secondary outcomes include isolating antibodies from various patient groups. This study will continue until 2028 and helps improve understanding of autoimmune encephalitis and related disorders.
CONDITIONS
Brief Title
Study of Pathogenic Mechanisms and Identification of Novel Autoantibodies in Autoimmune Encephalitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years of age
- Patients able to provide informed consent
- Patients diagnosed with autoimmune encephalitis associated with anti-NMDAR, GABABR, AMPAR, LGI-1, DNER antibodies, seronegative autoimmune encephalitis, or Susac syndrome without other autoimmune diseases
- Control group patients without autoimmune encephalitis or these specific antibodies
- Control group patients with other neurological disorders without antibodies against neuronal antigens
You will not qualify if you...
- Patients 18 years of age or younger
- Deceased patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo diagnostic procedures to identify specific antibodies associated with autoimmune encephalitis or other neurological disorders.
1 to 2 visits depending on antibody testing
Duration - Up to 12 months
Participants are observed over an extended period to study pathogenic mechanisms and identify novel autoantibodies using advanced technologies.
Periodic visits over 12 months
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, Italy, 00168
Actively Recruiting
Research Team
R
Raffaele Iorio
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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