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RecruitingNCT06183788

Antibody-mediated NMDA Receptor Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Prolonged Recovery Stage

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Fundacion Clinic per a la Recerca Biomédica · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

The encephalitis mediated by antibodies against the NMDA receptor (NMDARe) predominantly affects young adults and children resulting in severe neurologic and psychiatric deficits. After overcoming the acute stage, patients are left with long-lasting behavioral, cognitive, and psychiatric alterations with important socio-family-economical implications. Here investigators postulate that a better knowledge of this stage will improve treatment decisions and outcome. 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRemote cognitive rehabilitation programRemote 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).

Timeline

Start date
2023-01-16
Primary completion
2025-01-01
Completion
2025-11-30
First posted
2023-12-28
Last updated
2024-05-06

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06183788. Inclusion in this directory is not an endorsement.

Antibody-mediated NMDA Receptor Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Prolonged Recovery Stage (NCT06183788) · Clinical Trials Directory