Cognitive ImpairmentNCT03530462
To Explore Cognitive Neural Mechanism of Autoimmune Encephalitis by Using Neuropsychological Tests and Multi-modal MRI
An observational study of Cognitive Impairment and Autoimmune Encephalitis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Autoimmune Encephalitis
- What is being tested?
- rituximab, cyclophosphamide and Steroids
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2017to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients with autoimmune encephalitis and healthy control
Who may be able to join
None listed.
Who cannot join
- age >60 years or <16 years
- notable lesions, such as tumors, scars, or vascular malformations, on brain MRI
- a history of other neuropsychiatric disorders. -
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: The Usage of Neuropsychological Tests and Multi-mode Magnetic Resonance Imaging in Patients With Autoimmune Encephalitis for Cognitive Neural Mechanism
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.
Read the 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.
- Conditions
- Cognitive Impairment, Autoimmune Encephalitis
- Being tested
- rituximab, cyclophosphamide, Steroids, Intravenous immunoglobulin
- Keywords
- episodic memory, executive control, fMRI
- Medical subject headings
- Cognitive Dysfunction, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Also called rituximab injection
375 mg/m2 weekly for 4 weeks
cyclophosphamideDrug
Also called cyclophosphamide injection
750 mg/m2 monthly for 4-6 cycles depending on the response
SteroidsDrug
Also called methylprednisolone
500-1000 mg of methylprednisolone daily for 3 days, then tapered doses
Intravenous immunoglobulinDrug
Also called IVIG
intravenous immunoglobulin (IVIG) with or without plasmapheresis
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Drug: Steroids; Drug: Intravenous immunoglobulin | |
| healthy control | healthy individuals without a history of psychiatric or neurologic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain functional connectivity changes
The study uses multi-model fMRI to measure changes of functional connectivity across regions during recovery
Measured: a minimum of 6 months following initial discharge from hospital
Secondary outcomes (9)
verbal episodic memory
Chinese auditory verbal learning test (CAVLT)
Measured: a minimum of 6 months following initial discharge from hospital
non-verbal episodic memory
Aggie Figures Learning Test (AFLT)
Measured: a minimum of 6 months following initial discharge from hospital
working memory
working memory test
Measured: a minimum of 6 months following initial discharge from hospital
emotion-anxiety
self-rating anxiety scale (SAS),the *total* range (20-80 scores), anxiety state (the total score is equal or above 41)
Measured: a minimum of 6 months following initial discharge from hospital
emotion-depression
self-rating depression scale (SDS), the *total* range (20-80 scores), depression state (the total score is equal or above 41)
Measured: a minimum of 6 months following initial discharge from hospital
executive control
Stroop test
Measured: a minimum of 6 months following initial discharge from hospital
information processing speed
symbol-digit modalities test (SDMT)
Measured: a minimum of 6 months following initial discharge from hospital
visual-spatial ability
block design test
Measured: a minimum of 6 months following initial discharge from hospital
semantic fluency test
vegetable and fruit, animal
Measured: a minimum of 6 months following initial discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start7 Apr 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benyan Luo, Ph.D, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530462
- Sponsor's protocol ID
- multi-mode MRIs- encephalitis
- Status last verified
- Feb 2018
- First submitted
- 18 Mar 2018
- Last updated
- 21 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usage of Neuropsychological Tests and Multi-mode Magnetic Resonance Imaging in Patients With Autoimmune Encephalitis for Cognitive Neural Mechanism
- ClinicalTrials.gov ID
- NCT03530462
- Acronym / sponsor ID
- multi-mode MRIs- encephalitis
- Conditions
- Cognitive Impairment, Autoimmune Encephalitis
- Keywords
- episodic memory, executive control, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient with first-line and second-line | – | Drug: rituximab, Drug: cyclophosphamide, Drug: Steroids, Drug: Intravenous immunoglobulinpatients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide) |
| patients with first-line only | – | Drug: Steroids, Drug: Intravenous immunoglobulinpatients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only |
| healthy control | – | –healthy individuals without a history of psychiatric or neurologic disease |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients with autoimmune encephalitis and healthy control
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- age >60 years or <16 years
- notable lesions, such as tumors, scars, or vascular malformations, on brain MRI
- a history of other neuropsychiatric disorders. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximabAlso: rituximab injection375 mg/m2 weekly for 4 weeks | Drug | patient with first-line and second-line |
| cyclophosphamideAlso: cyclophosphamide injection750 mg/m2 monthly for 4-6 cycles depending on the response | Drug | patient with first-line and second-line |
| SteroidsAlso: methylprednisolone500-1000 mg of methylprednisolone daily for 3 days, then tapered doses | Drug | patient with first-line and second-line, patients with first-line only |
| Intravenous immunoglobulinAlso: IVIGintravenous immunoglobulin (IVIG) with or without plasmapheresis | Drug | patient with first-line and second-line, patients with first-line only |
Primary outcome
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
9 secondary outcomes
verbal episodic memory
Time frame: a minimum of 6 months following initial discharge from hospital
non-verbal episodic memory
Time frame: a minimum of 6 months following initial discharge from hospital
working memory
Time frame: a minimum of 6 months following initial discharge from hospital
emotion-anxiety
Time frame: a minimum of 6 months following initial discharge from hospital
emotion-depression
Time frame: a minimum of 6 months following initial discharge from hospital
executive control
Time frame: a minimum of 6 months following initial discharge from hospital
information processing speed
Time frame: a minimum of 6 months following initial discharge from hospital
visual-spatial ability
Time frame: a minimum of 6 months following initial discharge from hospital
semantic fluency test
Time frame: a minimum of 6 months following initial discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Individual participant dataSharing planned: No
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benyan Luo, Ph.D principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Autoimmune Encephalitis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain functional connectivity changes (time frame: a minimum of 6 months following initial discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.