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

• ClinicalTrials.gov Identifier: NCT03530462
• Recruitment Status: Completed
• First Posted: May 21, 2018
• Last Update Posted: May 21, 2018
• Sponsor: First Affiliated Hospital of Zhejiang University
• Information provided by (Responsible Party): First Affiliated Hospital of Zhejiang University

Study Description

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.

Condition or disease	Intervention/treatment
Cognitive Impairment; Autoimmune Encephalitis	Drug: rituximab; Drug: cyclophosphamide; Drug: Steroids; Drug: Intravenous immunoglobulin

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 22 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: The Usage of Neuropsychological Tests and Multi-mode Magnetic Resonance Imaging in Patients With Autoimmune Encephalitis for Cognitive Neural Mechanism
• Actual Study Start Date: April 7, 2017
• Actual Primary Completion Date: February 28, 2018
• Actual Study Completion Date: February 28, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
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)	Drug: rituximab; 375 mg/m2 weekly for 4 weeks; Other Name: rituximab injection; Drug: cyclophosphamide; 750 mg/m2 monthly for 4-6 cycles depending on the response; Other Name: cyclophosphamide injection; Drug: Steroids; 500-1000 mg of methylprednisolone daily for 3 days, then tapered doses; Other Name: methylprednisolone; Drug: Intravenous immunoglobulin; intravenous immunoglobulin (IVIG) with or without plasmapheresis; Other Name: IVIG
patients with first-line only; patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only	Drug: Steroids; 500-1000 mg of methylprednisolone daily for 3 days, then tapered doses; Other Name: methylprednisolone; Drug: Intravenous immunoglobulin; intravenous immunoglobulin (IVIG) with or without plasmapheresis; Other Name: IVIG
healthy control; healthy individuals without a history of psychiatric or neurologic disease

Outcome Measures

Primary Outcome Measures :

1. brain functional connectivity changes [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   The study uses multi-model fMRI to measure changes of functional connectivity across regions during recovery

Secondary Outcome Measures :

1. verbal episodic memory [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   Chinese auditory verbal learning test (CAVLT)
2. non-verbal episodic memory [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   Aggie Figures Learning Test (AFLT)
3. working memory [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   working memory test
4. emotion-anxiety [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   self-rating anxiety scale (SAS),the *total* range (20-80 scores), anxiety state (the total score is equal or above 41)
5. emotion-depression [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   self-rating depression scale (SDS), the *total* range (20-80 scores), depression state (the total score is equal or above 41)
6. executive control [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   Stroop test
7. information processing speed [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   symbol-digit modalities test (SDMT)
8. visual-spatial ability [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   block design test
9. semantic fluency test [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
   vegetable and fruit, animal

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 60 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

patients with autoimmune encephalitis and healthy control

Criteria

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. -

Contacts and Locations

Locations

China, Zhejiang

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Sponsors and Collaborators

First Affiliated Hospital of Zhejiang University

Investigators

• Principal Investigator: Benyan Luo, Ph.D; The First Affiliated Hospital, Zhejiang University

More Information

• Responsible Party: First Affiliated Hospital of Zhejiang University
• ClinicalTrials.gov Identifier: NCT03530462
• Other Study ID Numbers: multi-mode MRIs- encephalitis
• First Posted: May 21, 2018
• Last Update Posted: May 21, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital of Zhejiang University:

episodic memory; executive control; fMRI

Additional relevant MeSH terms:

Encephalitis; Hashimoto Disease; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Methylprednisolone; Cyclophosphamide; Rituximab; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antineoplastic Agents, Immunological; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents