Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This study aims to develop non-invasive, in vivo measures of neurobiological dysfunction derived from the overarching hypothesis that dysfunction of inhibitory interneurons alters the cerebral concentrations of gamma-aminobutyric acid (GABA) and glutamate (Glu) and underlies T2 changes and deficient connectivity in functional networks in early recovery from NMDAR-antibody encephalitis. Our ambition is to identify the best potential prognostic biomarkers from these neurometabolite measurements and structural and functional MRI. Our primary objective is to test the following specific hypotheses in children and young people with NMDAR-antibody encephalitis: - Hypothesis 1: GABA is decreased, and Glu increased, on MR spectroscopy of the medial temporal lobe and medial prefrontal cortex in NMDAR-antibody encephalitis. - Hypothesis 2: Local GABA and Glu are correlated with (i) resting-state functional MRI (fMRI) based functional connectivity and (ii) parameter map-based microstructural changes. Specifically, we hypothesise that (i) GABA is positively correlated and Glu inversely correlated with functional connectivity, assessed by whole-brain mapping of the default mode network and seed-based analysis of hippocampal-frontal connectivity; and (ii) Glu is positively correlated and GABA inversely correlated with median T2 values within the hippocampus. - Hypothesis 3: Local neurometabolites, network measures and microstructural changes predict cognitive, psychiatric and functional outcome at one year. Specifically, we hypothesise that medial temporal Glu, GABA and hippocampal T2 predict memory performance, and prefrontal Glu and GABA predict attention, executive function and fluid intelligence. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05280600
Study type Observational
Source King's College London
Contact Michael R Eyre, MBBS MRes
Phone +44 207 1887188
Email michael.eyre@kcl.ac.uk
Status Recruiting
Phase
Start date May 19, 2022
Completion date February 28, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04561557 - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System Early Phase 1
Completed NCT05645185 - Characterisation of Clinical Phenotypes and Outcomes of Ma2 Patient
Completed NCT04708626 - Epidemiology of Autoimmune Encephalitides and Paraneoplastic Neurological Syndromes in Sweden
Not yet recruiting NCT04106596 - HLA Analysis in Autoimmune Encephalitis and Related Disorders
Not yet recruiting NCT05711563 - Predicting and Monitoring Outcomes in Autoimmune Encephalitis
Completed NCT04175522 - Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis: Phase 2
Recruiting NCT03194815 - IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2 Phase 2
Recruiting NCT06079294 - Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism N/A
Not yet recruiting NCT03957616 - Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis
Completed NCT02905136 - Mechanisms of Auto-immune Encephalitis
Recruiting NCT06173076 - A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis
Recruiting NCT03993262 - Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis Phase 2
Recruiting NCT06033846 - Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis Phase 2
Recruiting NCT04372615 - The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis Phase 2
Recruiting NCT05177939 - Phase III Clinical Study of NPB-01 in Patients With Autoimmune Encephalitis Phase 3
Active, not recruiting NCT06432803 - Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS
Recruiting NCT06019975 - FDG-PET in the Diagnosis of Autoimmune Encephalitis
Completed NCT05783947 - Diagnostic Performance of a Commercial Assay for the Detection of Neuronal Antibodies
Not yet recruiting NCT06456736 - Clinical Features and Prognostic Markers in Adult Patients With AE Requiring ICU Treatment
Completed NCT05825690 - BRIEF TITLE * (in English and Sufficiently Descriptive) Role of MRI in Anti-LGI1 Encephalitis