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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530462
• Other study ID #: multi-mode MRIs- encephalitis
• Status: Completed
• Start date: April 7, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: February 2018
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Autoimmune Encephalitis
• Cognitive Dysfunction
• Cognitive Impairment
• Encephalitis
• Hashimoto Disease

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain functional connectivity changes	The study uses multi-model fMRI to measure changes of functional connectivity across regions during recovery	a minimum of 6 months following initial discharge from hospital
Secondary	verbal episodic memory	Chinese auditory verbal learning test (CAVLT)	a minimum of 6 months following initial discharge from hospital
Secondary	non-verbal episodic memory	Aggie Figures Learning Test (AFLT)	a minimum of 6 months following initial discharge from hospital
Secondary	working memory	working memory test	a minimum of 6 months following initial discharge from hospital
Secondary	emotion-anxiety	self-rating anxiety scale (SAS),the *total* range (20-80 scores), anxiety state (the total score is equal or above 41)	a minimum of 6 months following initial discharge from hospital
Secondary	emotion-depression	self-rating depression scale (SDS), the *total* range (20-80 scores), depression state (the total score is equal or above 41)	a minimum of 6 months following initial discharge from hospital
Secondary	executive control	Stroop test	a minimum of 6 months following initial discharge from hospital
Secondary	information processing speed	symbol-digit modalities test (SDMT)	a minimum of 6 months following initial discharge from hospital
Secondary	visual-spatial ability	block design test	a minimum of 6 months following initial discharge from hospital
Secondary	semantic fluency test	vegetable and fruit, animal	a minimum of 6 months following initial discharge from hospital