Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 18, 2018
First Posted Date May 21, 2018
Last Update Posted Date May 21, 2018
Actual Study Start Date April 7, 2017
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 7, 2018)
  • verbal episodic memory [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
    Chinese auditory verbal learning test (CAVLT)
  • non-verbal episodic memory [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
    Aggie Figures Learning Test (AFLT)
  • working memory [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
    working memory test
  • 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)
  • 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)
  • executive control [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
    Stroop test
  • information processing speed [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
    symbol-digit modalities test (SDMT)
  • visual-spatial ability [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
    block design test
  • semantic fluency test [ Time Frame: a minimum of 6 months following initial discharge from hospital ]
    vegetable and fruit, animal
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title To Explore Cognitive Neural Mechanism of Autoimmune Encephalitis by Using Neuropsychological Tests and Multi-modal MRI
Official Title The Usage of Neuropsychological Tests and Multi-mode Magnetic Resonance Imaging in Patients With Autoimmune Encephalitis for Cognitive Neural Mechanism
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with autoimmune encephalitis and healthy control
Condition
  • Cognitive Impairment
  • Autoimmune Encephalitis
Intervention
  • 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
Study Groups/Cohorts
  • 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)
    Interventions:
    • Drug: rituximab
    • Drug: cyclophosphamide
    • Drug: Steroids
    • Drug: Intravenous immunoglobulin
  • patients with first-line only
    patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only
    Interventions:
    • Drug: Steroids
    • Drug: Intravenous immunoglobulin
  • healthy control
    healthy individuals without a history of psychiatric or neurologic disease
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2018)
22
Original Actual Enrollment Same as current
Actual Study Completion Date February 28, 2018
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility 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. -
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03530462
Other Study ID Numbers multi-mode MRIs- encephalitis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party First Affiliated Hospital of Zhejiang University
Study Sponsor First Affiliated Hospital of Zhejiang University
Collaborators Not Provided
Investigators
Principal Investigator: Benyan Luo, Ph.D The First Affiliated Hospital, Zhejiang University
PRS Account First Affiliated Hospital of Zhejiang University
Verification Date February 2018