Evaluating outcomes in patients with anti-LGI1 encephalitis
A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis
This study is trying to see how patients with a specific type of autoimmune encephalitis, called anti-LGI1 encephalitis, do over time by looking at their symptoms and test results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06173076 on ClinicalTrials.gov |
What this trial studies
This observational study aims to prospectively evaluate clinical outcomes in patients diagnosed with anti-LGI1 encephalitis, a type of autoimmune encephalitis. The study will recruit newly diagnosed patients during the acute stage and will utilize a variety of advanced paraclinical examinations, including blood tests, MRI, EEG, and neuropsychological assessments. By analyzing these clinical features and outcomes, the researchers hope to identify factors associated with the disease's progression and treatment response.
Who should consider this trial
Good fit: Ideal candidates are individuals who have been newly diagnosed with anti-LGI1 encephalitis during the acute stage.
Not a fit: Patients with prior neurological conditions or coexisting antibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of anti-LGI1 encephalitis and lead to better management strategies for affected patients.
How similar studies have performed: While there have been limited prospective studies on anti-LGI1 encephalitis, this approach aims to fill a gap in understanding clinical outcomes, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meet the 2016 consensus diagnostic criteria for anti-LGI1 encephalitis. 2. Newly diagnosed, and during the acute stage before study enrollment. 3. Sign the informed consent form. Exclusion Criteria: 1. with the diagnosis of epilepsy, stroke, cerebral trauma, and/or other nervous system disease prior to the onset of encephalitis. 2. with coexisting antibodies, such as anti-contactin-associated protein 2 (CASPR2) antibody. 3. Lost to follow-up.
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Chun-Hong Shen — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
- Study coordinator: Mei-Ping Ding
- Email: dmp-neurology@zju.edu.cn
- Phone: +86 0571 87783872
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.