Clinical Trials Directory

Trials / Completed

CompletedNCT03530462

To Explore Cognitive Neural Mechanism of Autoimmune Encephalitis by Using Neuropsychological Tests and Multi-modal MRI

The Usage of Neuropsychological Tests and Multi-mode Magnetic Resonance Imaging in Patients With Autoimmune Encephalitis for Cognitive Neural Mechanism

Status
Completed
Phase
Study type
Observational
Enrollment
22 (actual)
Sponsor
First Affiliated Hospital of Zhejiang University · Academic / Other
Sex
All
Age
16 Years – 60 Years
Healthy volunteers
Accepted

Summary

Most of patients with autoimmune encephalitis are left with permanent cognitive deficits of varying severity. The patients' life and career would be affected definitely by cognitive deficits. Recently, more and more clinical physician have begun to focus on cognitive impairment of patients with autoimmune encephalitis. Generally, the outcome was measured by the modified Rankin Scale (mRS). However, the mRS are commonly used to evaluate the degree of disability or dependence in the daily activities of the patients suffering from a stroke and cognition function were minimally evaluated in this scale. It is crucial to adopt detailed cognition tools to study the long-term cognitive outcomes and as an indicator of overall curative effect judgment in autoimmune encephalitis. Currently, only early immunotherapy is uniformly and consistently considered to produce favorable cognitive outcomes. However, studies concerning the association of second-line immunotherapy with cognitive outcomes have been scarce and have shown conflicting results regarding autoimmune encephalitis. Hence, the goal of this study was to explore cognitive neural mechanism of autoimmune encephalitis by using neuropsychological tests and multi-mode MRIs.

Detailed description

The goal of this study was to explore cognitive neural mechanism of different types of autoimmune encephalitis by using neuropsychological tests and multi-mode MRIs. Neuropsychological tests involves the assessments of different cognitive domains. And multi-mode MRIs contains resting-fMRI, DTI and task-related fMRI.

Conditions

Interventions

TypeNameDescription
DRUGrituximab375 mg/m2 weekly for 4 weeks
DRUGcyclophosphamide750 mg/m2 monthly for 4-6 cycles depending on the response
DRUGSteroids500-1000 mg of methylprednisolone daily for 3 days, then tapered doses
DRUGIntravenous immunoglobulinintravenous immunoglobulin (IVIG) with or without plasmapheresis

Timeline

Start date
2017-04-07
Primary completion
2018-02-28
Completion
2018-02-28
First posted
2018-05-21
Last updated
2018-05-21

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03530462. Inclusion in this directory is not an endorsement.