Antibody-mediated NMDA Receptor Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Prolonged Recovery Stage
NCT ID: NCT06183788
Last Updated: 2024-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-01-16
2025-11-30
Brief Summary
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In Aim 1, the post-acute stage will be clinically characterized, tools to remotely follow cognitive, behavioral and psychiatric deficits will be provided, and the impact of cognitive rehabilitation will be assessed.
In Aim 2, biomarkers (autoimmune, inflammatory, neuronal injury) will be identified as signatures of the acute and post-acute stages.
In Aim 3, a mouse model of NMDARe will be used to determine the underlying mechanisms and treatment of the postacute stage.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Anti-NMDARe patients with remote cognitive rehabilitation
Participants of a prospective cohort in post-acute phase of the Antibody-mediated NMDA Receptor Encephalitis that will received a behavioral treatment.
Remote cognitive rehabilitation program
Remote cognitive rehabilitation program will be performed through an online validated platform (Guttmann NeuroPersonalTrainer: https://gnpt.es/) run by the psychologists team. This is a Sanitary Product with CE certification (Sanitary Product RPS/430/2014; International Patent \[PCT/ES2008/00677\]) and here will be used within its approved indications. The rehabilitation program will increase in difficulty and decrease in frequency during the first year of follow-up (V1-V3).
Interventions
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Remote cognitive rehabilitation program
Remote cognitive rehabilitation program will be performed through an online validated platform (Guttmann NeuroPersonalTrainer: https://gnpt.es/) run by the psychologists team. This is a Sanitary Product with CE certification (Sanitary Product RPS/430/2014; International Patent \[PCT/ES2008/00677\]) and here will be used within its approved indications. The rehabilitation program will increase in difficulty and decrease in frequency during the first year of follow-up (V1-V3).
Eligibility Criteria
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Inclusion Criteria
* ≤6 months from hospital discharge (acute phase)
Exclusion Criteria
* inability to travel to the center.
12 Years
ALL
No
Sponsors
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Hospital Sant Joan de Deu
OTHER
Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
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Principal Investigators
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Josep Dalmau, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínic
Locations
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Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Guasp M, Rosa-Justicia M, Munoz-Lopetegi A, Martinez-Hernandez E, Armangue T, Sugranyes G, Stein H, Borras R, Prades L, Arino H, Planaguma J, De-La-Serna E, Escudero D, Llufriu S, Sanchez-Valle R, Santamaria J, Compte A, Castro-Fornieles J, Dalmau J; Spanish anti-NMDAR Encephalitis Study Group. Clinical characterisation of patients in the post-acute stage of anti-NMDA receptor encephalitis: a prospective cohort study and comparison with patients with schizophrenia spectrum disorders. Lancet Neurol. 2022 Oct;21(10):899-910. doi: 10.1016/S1474-4422(22)00299-X.
Titulaer MJ, McCracken L, Gabilondo I, Armangue T, Glaser C, Iizuka T, Honig LS, Benseler SM, Kawachi I, Martinez-Hernandez E, Aguilar E, Gresa-Arribas N, Ryan-Florance N, Torrents A, Saiz A, Rosenfeld MR, Balice-Gordon R, Graus F, Dalmau J. Treatment and prognostic factors for long-term outcome in patients with anti-NMDA receptor encephalitis: an observational cohort study. Lancet Neurol. 2013 Feb;12(2):157-65. doi: 10.1016/S1474-4422(12)70310-1. Epub 2013 Jan 3.
Arino H, Munoz-Lopetegi A, Martinez-Hernandez E, Armangue T, Rosa-Justicia M, Escudero D, Matos N, Graus F, Sugranyes G, Castro-Fornieles J, Compte A, Dalmau J, Santamaria J. Sleep disorders in anti-NMDAR encephalitis. Neurology. 2020 Aug 11;95(6):e671-e684. doi: 10.1212/WNL.0000000000009987. Epub 2020 Jun 23.
Finke C, Kopp UA, Scheel M, Pech LM, Soemmer C, Schlichting J, Leypoldt F, Brandt AU, Wuerfel J, Probst C, Ploner CJ, Pruss H, Paul F. Functional and structural brain changes in anti-N-methyl-D-aspartate receptor encephalitis. Ann Neurol. 2013 Aug;74(2):284-96. doi: 10.1002/ana.23932. Epub 2013 Jul 8.
Heine J, Kopp UA, Klag J, Ploner CJ, Pruss H, Finke C. Long-Term Cognitive Outcome in Anti-N-Methyl-D-Aspartate Receptor Encephalitis. Ann Neurol. 2021 Dec;90(6):949-961. doi: 10.1002/ana.26241. Epub 2021 Oct 21.
Armangue T, Titulaer MJ, Malaga I, Bataller L, Gabilondo I, Graus F, Dalmau J; Spanish Anti-N-methyl-D-Aspartate Receptor (NMDAR) Encephalitis Work Group. Pediatric anti-N-methyl-D-aspartate receptor encephalitis-clinical analysis and novel findings in a series of 20 patients. J Pediatr. 2013 Apr;162(4):850-856.e2. doi: 10.1016/j.jpeds.2012.10.011. Epub 2012 Nov 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form: IC for adult patients
Document Type: Informed Consent Form: IC for adult familiar
Document Type: Informed Consent Form: IC for minors/patients under the age of 18
Document Type: Informed Consent Form: IC for familiar of minors/patients under the age of 18
Other Identifiers
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HR22-00221
Identifier Type: -
Identifier Source: org_study_id
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