Developing Advanced Neuroimaging for Clinical Evaluation of Autoimmune Encephalitis
DANCE-AE
3 other identifiers
observational
75
1 country
1
Brief Summary
Autoimmune encephalitis is brain inflammation caused by the immune system mistakenly reacting against proteins in the brain. The commonest form is called NMDAR-antibody encephalitis (N-methyl-D-aspartate receptor antibody encephalitis), a rare condition which mainly affects children and young people and causes difficulties in memory, thinking and mental health which can have significant long-term impacts on education, employment and quality of life. In this project we will use advanced magnetic resonance imaging (MRI) to measure changes in the structure, function and chemistry of the brains of children and young people who are in early recovery from NMDAR-antibody encephalitis and other forms of immune-mediated encephalitis. We will investigate if MRI measurements in patients differ from those in healthy people, and if they can help predict patient outcome one year later, assessed by tests of memory, thinking, mental health and functioning in daily life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Start
First participant enrolled
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedOctober 6, 2023
October 1, 2023
1.8 years
February 10, 2022
October 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cerebral concentrations of GABA and glutamate at the prefrontal cortex and left medial temporal lobe
Measured with MR spectroscopy - stimulated echo acquisition mode (STEAM) sequence
Baseline
Structural MRI
Quantitative MRI parameter maps including measurement of median T2 values in the hippocampus
Baseline
Resting-state fMRI
Whole-brain mapping of the default mode network and seed-based analysis of hippocampal-frontal connectivity
Baseline
Secondary Outcomes (16)
Wechsler Abbreviated Scale of Intelligence 2nd Edition (WASI-II)
Baseline (all groups), 1 year (patients)
Rey Auditory Verbal Learning Test (RAVLT)
Baseline (all groups), 1 year (patients)
Doors & People Test
Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Paired Associates Learning
Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Rapid Visual Information Processing
Baseline (all groups), 1 year (patients)
- +11 more secondary outcomes
Study Arms (3)
NMDAR-antibody encephalitis
Children and young people (ages 8-24 years) with a diagnosis of NMDAR-antibody encephalitis.
Antibody-negative autoimmune encephalitis
Children and young people (ages 8-24 years) with a diagnosis of autoantibody-negative but probable autoimmune encephalitis or definite autoimmune limbic encephalitis.
Healthy control
Healthy children and young people (ages 8-24 years).
Interventions
Not applicable - non-interventional study
Eligibility Criteria
All participants will be recruited in the United Kingdom. NMDAR-antibody encephalitis and antibody-negative autoimmune encephalitis groups: Identified by neurologists/paediatric neurologists in secondary/tertiary healthcare settings, or by self-referral via the Encephalitis Society. Healthy control group: Identified from King's College London volunteer databases, friends and siblings of autoimmune encephalitis cases, or recruited from local schools and colleges.
You may qualify if:
- NMDAR-antibody encephalitis group:
- Age 8-24 years at study enrollment.
- Disease onset in the last 12 months before study enrollment.
- Meets consensus diagnostic criteria (Graus et al., 2016) for either probable anti-NMDAR encephalitis OR definite anti-NMDAR encephalitis.
- Antibody-negative autoimmune encephalitis group:
- Age 8-24 years at study enrollment.
- Disease onset in the last 12 months before study enrollment.
- Meets consensus diagnostic criteria (Graus et al., 2016) for either autoantibody-negative but probable autoimmune encephalitis OR definite autoimmune limbic encephalitis.
- Healthy control group:
- \. Age 8-24 years at study enrollment.
You may not qualify if:
- All participants:
- \. Any clear contra-indication for an MRI scan. In particular this would be due to the presence of any implanted devices or metal from previous surgery or accident.
- Healthy control group:
- \. A known neurological or neurodevelopmental disorder.
- NMDAR-antibody encephalitis and antibody-negative autoimmune encephalitis groups:
- Severe movement disorder/uncontrolled epilepsy/dysautonomia.
- Previous infective encephalitis with major destructive brain lesions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- Guy's and St Thomas' NHS Foundation Trustcollaborator
- Action Medical Researchcollaborator
Study Sites (1)
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 7EH, United Kingdom
Related Publications (1)
Graus F, Titulaer MJ, Balu R, Benseler S, Bien CG, Cellucci T, Cortese I, Dale RC, Gelfand JM, Geschwind M, Glaser CA, Honnorat J, Hoftberger R, Iizuka T, Irani SR, Lancaster E, Leypoldt F, Pruss H, Rae-Grant A, Reindl M, Rosenfeld MR, Rostasy K, Saiz A, Venkatesan A, Vincent A, Wandinger KP, Waters P, Dalmau J. A clinical approach to diagnosis of autoimmune encephalitis. Lancet Neurol. 2016 Apr;15(4):391-404. doi: 10.1016/S1474-4422(15)00401-9. Epub 2016 Feb 20.
PMID: 26906964BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David W Carmichael, PhD MSci
King's College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2022
First Posted
March 15, 2022
Study Start
May 19, 2022
Primary Completion
February 28, 2024
Study Completion
February 28, 2026
Last Updated
October 6, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- To be confirmed
- Access Criteria
- Requests for data access from researchers at accredited research institutions will be considered. Any requests for data sharing may require a formal agreement to be put in place between the Sponsors and the recipient.
Consent will be requested from participants to share imaging data and summary clinical and demographic data. Where participants consent, imaging data will be de-identified, removing facial features from the magnetic resonance images and all identifying information will be removed from the image header (the part of the file that describes how the image data was acquired). The resulting data will be shared together with anonymised clinical data at the request of other researchers.