Our aims are to identify the clusters of impairments in cognition, behavior, quality of life, and fatigue in children after anti-NMDAR encephalitis, to identify risk factors affecting functional outcome and to assess the progression or remission…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Encephalopathies
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identification of clusters of impairment in cognition and behavior after
pediatric anti-NMDAR encephalitis
Secondary outcome
- Identification of risk factors affecting functional outcome
- Analyzing progression or remission over time
- Analyzing the phenomenom of 'growing into deficit'
Background summary
Anti-NMDAR encephalitis is a recently discovered new disease. Forty percent of
patients are children, and it is the most common immune-mediated disease in
children, beyond acute disseminated encephalomyelitis (ADEM) or acquired
demyelinating syndromes (ADS). Anti-NMDAR encephalitis is a severe disease, and
75% of patients are admitted to the pediatric ICU. However, patients can
recover well with adequate immunotherapy. Our large observational cohort study
has shown that 85% of children recover *well*, although it can take up to 24
months. Despite good recovery, there is evidence that many patients are left
with neuropsychological and behavioral impairments, but the exact extent is
unknown. Formal neuropsychological assessment is only described in two
international studies including nine adults and two children. These two small
studies found impairments in memory, attention, behavior, and executive
functioning.
Study objective
Our aims are to identify the clusters of impairments in cognition, behavior,
quality of life, and fatigue in children after anti-NMDAR encephalitis, to
identify risk factors affecting functional outcome and to assess the
progression or remission over time. There will be special emphasis on the age
effect of *growing into deficit*.
Study design
A part of the study is cross-sectional (including children with anti-NDMAR
encephalitis before Jan 2015), another part is prospective (children with
anti-NMDAR encephalitis after Jan 2015)
Study burden and risks
Patients participating in the cross-sectional part of the study will be
assessed once. The duration of the assessment interview will be two hours.
Patients participating in the prospective part of the study will be assessed
briefly during hospital visit to their treating physician at three months, and
they will have a two hours assessment interview at 6, 12 and 24 months after
onset of disease.
Assessment has negligible risks, although the identified issues can possibly
lead to sadness.
Anti-NMDAR encephalitis is freqently seen in children (40% of the cases). The
study goal can not be achieved analyzing adult patients, because the brain and
immune system are different in children.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
- Cross-sectional part: patients who have had anti-NMDA receptor encephalitis before January 2015, who were age 18 or younger at disease onset and currently age 4 or older.
- Prospective parts: patients who have had anti-NMDA receptor encephalitis after January 2015, who were age 3.5 to 18 at disease onset
- Patient was diagnosed in Dutch tertiary pediatric hospitals, or antibody testing had been performed in our center.
- Patient speaks Dutch or English.
Exclusion criteria
- Age over 18 years at disease onset, or current age younger than 4
- Patient or legal representative is withholding informed consent
- Patient or legal representative objects after initial informed consent (see paragraph 8.4)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52688.078.15 |