NCT06173076 A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis
| NCT ID | NCT06173076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shen Chun-Hong |
| Condition | Autoimmune Encephalitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-05-18 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-05-18 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis has been increasingly identified as the second most common type of autoimmune encephalitis after anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis. It presents with acute or subacute onset of epileptic seizures, anterograde amnesia, behavior disturbances, sleep disorders and hyponatremia. In most patients with anti-LGI1 encephalitis, immunotherapy is successful in treating the encephalitis. However, relapses, chronic epilepsy, cognitive declines and psychiatric problems have been reported in some cases. So far, prospective studies to evaluate its clinical outcomes still remain limited. In this project, the investigators will use clinical features and advanced paraclinical examinations to prospectively investigate the clinical outcomes and the associated factors in patients with anti-LGI1 encephalitis.
Eligibility 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.
Contact & Investigator
Chun-Hong Shen
PRINCIPAL INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Frequently Asked Questions
Who can join the NCT06173076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Autoimmune Encephalitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06173076 currently recruiting?
Yes, NCT06173076 is actively recruiting participants. Contact the research team at dmp-neurology@zju.edu.cn for enrollment information.
Where is the NCT06173076 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06173076 clinical trial?
NCT06173076 is sponsored by Shen Chun-Hong. The principal investigator is Chun-Hong Shen at 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China. The trial plans to enroll 60 participants.