A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorShen Chun-Hong
About this trial
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
This trial does not accept healthy volunteersQualifiers
Meet the 2016 consensus diagnostic criteria for anti-LGI1 encephalitis.
Newly diagnosed, and during the acute stage before study enrollment.
Sign the informed consent form.
Disqualifiers
with the diagnosis of epilepsy, stroke, cerebral trauma, and/or other nervous system disease prior to the onset of encephalitis.
with coexisting antibodies, such as anti-contactin-associated protein 2 (CASPR2) antibody.
Lost to follow-up.
Trial population
the patients with anti-LGI1 encephalitis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
seizure outcomes
The incidence of different seizure outcomes and associated factors will be analyzed.
Time frame
1 year, 2 year2
Clinical severity and recovery 1
modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome
Time frame
1 year, 2 year3
Clinical severity and recovery 2
clinical assessment scale for autoimmune encephalitis, ranging from 0-27, higher scores mean a worse outcome
Time frame
1 year, 2 year4
Incidence of recurrence
a relapse of encephalitis
Time frame
1 year, 2 yearSecondary outcomes
1
Memory assessment 1
the Wechsler Memory Scale, high score means a good memory.
Time frame
1 year, 2 year2
Memory assessment 2
Rey Auditory Verbal Learning Test (RAVLT), high score means a good vebal episodic memory.
Time frame
1 year, 2 year3
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.
Time frame
1 year, 2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shen Chun-Hong
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor institution
Source ClinicalTrials.gov