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Trial record 35 of 40 for:    "Hashimoto thyroiditis" OR "Hashimoto Disease"

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

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

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.

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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


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



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



Information from the National Library of Medicine

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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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530462


Locations
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China, Zhejiang
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Investigators
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Principal Investigator: Benyan Luo, Ph.D The First Affiliated Hospital, Zhejiang University

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Responsible Party: First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03530462     History of Changes
Other Study ID Numbers: multi-mode MRIs- encephalitis
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Hashimoto Disease
Encephalitis
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thyroiditis, Autoimmune
Thyroiditis
Thyroid Diseases
Endocrine System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Cyclophosphamide
Rituximab
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs