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

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT03530462
Status
Completed

Conditions

  • Autoimmune Encephalitis
  • Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
16 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • rituximab — DRUG
    375 mg/m2 weekly for 4 weeks
  • cyclophosphamide — DRUG
    750 mg/m2 monthly for 4-6 cycles depending on the response
  • Steroids — DRUG
    500-1000 mg of methylprednisolone daily for 3 days, then tapered doses
  • Intravenous immunoglobulin — DRUG
    intravenous immunoglobulin (IVIG) with or without plasmapheresis

Study Details

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.

Key Dates

Start date
Apr 7, 2017
Status verified
Feb 2018
Primary completion
Feb 28, 2018
Completion
Feb 28, 2018

Study Design

Enrollment
22 participants (actual)

Arms

  • Arm: patient with first-line and second-line
    patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide)
  • Arm: patients with first-line only
    patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only
  • Arm: healthy control
    healthy individuals without a history of psychiatric or neurologic disease

Primary Outcome Measure

brain functional connectivity changes [ Time Frame: a minimum of 6 months following initial discharge from hospital ]

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