Autoimmune Encephalitis Clinical Trial
Official title:
A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis
NCT number | NCT06173076 |
Other study ID # | Y2022-0336 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 18, 2022 |
Est. completion date | December 31, 2032 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2032 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | seizure outcomes | The incidence of different seizure outcomes and associated factors will be analyzed. | 1 year, 2 year | |
Primary | Clinical severity and recovery 1 | modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome | 1 year, 2 year | |
Primary | Clinical severity and recovery 2 | clinical assessment scale for autoimmune encephalitis, ranging from 0-27, higher scores mean a worse outcome | 1 year, 2 year | |
Primary | Incidence of recurrence | a relapse of encephalitis | 1 year, 2 year | |
Secondary | Memory assessment 1 | the Wechsler Memory Scale, high score means a good memory. | 1 year, 2 year | |
Secondary | Memory assessment 2 | Rey Auditory Verbal Learning Test (RAVLT), high score means a good vebal episodic memory. | 1 year, 2 year | |
Secondary | Brain volume | with 3T magnetic resonance imaging (MRI), volumes of the whole hippocampus, hippocampal subfields and other relevant regions were determined using FreeSurfer. The unit of volume is described as mm3. | 1 year, 2 year |
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