NCT05280600|Unknown
Developing Advanced Neuroimaging for Clinical Evaluation of Autoimmune Encephalitis
DANCE-AE
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DANCE-AE
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Action Medical Research
OTHER · Health Research Authority
observational
75
1 country
1
Study Start
May 19, 2022
Actual (reported)Primary Completion
February 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 10, 2022
Actual (reported)March 15, 2022
Actual (reported)May 19, 2022
Actual (reported)February 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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)
Children and young people (ages 8-24 years) with a diagnosis of NMDAR-antibody 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 children and young people (ages 8-24 years).
Not applicable - non-interventional study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 7EH, United Kingdom
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.
David W Carmichael, PhD MSci
King's College London
First Submitted
February 10, 2022
First Posted
March 15, 2022
Study Start
May 19, 2022
Actual (reported)Primary Completion
February 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis
Phase III Clinical Study of NPB-01 in Patients With Autoimmune Encephalitis
Contact the study team to confirm eligibility.
Study Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 6, 2023
Record last verified: 2023-10
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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