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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03530462
Enrollment
22
Registered
2018-05-21
Start date
2017-04-07
Completion date
2018-02-28
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Encephalitis, Cognitive Impairment

Keywords

episodic memory, executive control, fMRI

Brief 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.

Interventions

DRUGrituximab

375 mg/m2 weekly for 4 weeks

DRUGcyclophosphamide

750 mg/m2 monthly for 4-6 cycles depending on the response

DRUGSteroids

500-1000 mg of methylprednisolone daily for 3 days, then tapered doses

DRUGIntravenous immunoglobulin

intravenous immunoglobulin (IVIG) with or without plasmapheresis

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Diagnosis was established in all patients based on characteristic clinical presentation and detection of immunoglobulin G (IgG) antibodies. \-

Exclusion criteria

1. age \>60 years or \<16 years 2. notable lesions, such as tumors, scars, or vascular malformations, on brain MRI 3. a history of other neuropsychiatric disorders. -

Design outcomes

Primary

MeasureTime frameDescription
brain functional connectivity changesa minimum of 6 months following initial discharge from hospitalThe study uses multi-model fMRI to measure changes of functional connectivity across regions during recovery

Secondary

MeasureTime frameDescription
non-verbal episodic memorya minimum of 6 months following initial discharge from hospitalAggie Figures Learning Test (AFLT)
working memorya minimum of 6 months following initial discharge from hospitalworking memory test
emotion-anxietya minimum of 6 months following initial discharge from hospitalself-rating anxiety scale (SAS),the \*total\* range (20-80 scores), anxiety state (the total score is equal or above 41)
emotion-depressiona minimum of 6 months following initial discharge from hospitalself-rating depression scale (SDS), the \*total\* range (20-80 scores), depression state (the total score is equal or above 41)
verbal episodic memorya minimum of 6 months following initial discharge from hospitalChinese auditory verbal learning test (CAVLT)
information processing speeda minimum of 6 months following initial discharge from hospitalsymbol-digit modalities test (SDMT)
visual-spatial abilitya minimum of 6 months following initial discharge from hospitalblock design test
semantic fluency testa minimum of 6 months following initial discharge from hospitalvegetable and fruit, animal
executive controla minimum of 6 months following initial discharge from hospitalStroop test

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026