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

NCT ID: NCT03530462

Last Updated: 2018-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-07

Study Completion Date

2018-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Impairment Autoimmune Encephalitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

rituximab

Intervention Type DRUG

375 mg/m2 weekly for 4 weeks

cyclophosphamide

Intervention Type DRUG

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

Steroids

Intervention Type DRUG

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

Intravenous immunoglobulin

Intervention Type DRUG

intravenous immunoglobulin (IVIG) with or without plasmapheresis

patients with first-line only

patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only

Steroids

Intervention Type DRUG

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

Intravenous immunoglobulin

Intervention Type DRUG

intravenous immunoglobulin (IVIG) with or without plasmapheresis

healthy control

healthy individuals without a history of psychiatric or neurologic disease

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rituximab

375 mg/m2 weekly for 4 weeks

Intervention Type DRUG

cyclophosphamide

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

Intervention Type DRUG

Steroids

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

Intervention Type DRUG

Intravenous immunoglobulin

intravenous immunoglobulin (IVIG) with or without plasmapheresis

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

rituximab injection cyclophosphamide injection methylprednisolone IVIG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

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. -
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benyan Luo, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

multi-mode MRIs- encephalitis

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.