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Recruiting NCT07158229

Long-term Impact of NMDAR Encephalitis, Level 3

— Observational NMDAR Autoimmune Encephalitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: NMDAR Autoimmune Encephalitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Social and Psychological Long-term Impact of NMDA Receptor Encephalitis, Level 3

Overview

NMDA receptor antibody encephalitis is a rare autoimmune neurological disease of the central nervous system with an estimated incidence of 1.5 people per million per year. Patients with anti-NMDAR encephalitis experience an acute phase of the disease characterized by psychosis, memory loss, seizures, autonomic nervous system instability, or coma. Since the discovery of this disease 14 years ago by Prof. Dalmau, the clinical presentation of the acute phase has been well characterized, while the psychosocial impact of the disease remains largely unexplored. Currently, there are few cohort studies of patients that have identified persistent cognitive impairment as a factor impacting remission after the acute phase. Given the scarcity of information concerning the post-acute phase, it is therefore essential to determine the long-term social and psychological outcomes and their daily effects on the social and functional life of this severe disease. This is especially important as the patients are young, with a median age of 21 years, and may face lasting limitations potentially detrimental to their success in professional, educational, or social environments.

Interventions

  • Other Questionnaires
    Complete quality of life questionnaires focusing on fatigue, anxiety, depression, and sleep.

Primary outcome measures

  • Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PREMS questionnaires - AEPREM questionnaire [Time frame: At inclusion]
  • Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PREMS questionnaire - AESOC [Time frame: At inclusion]
  • Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaires - FSS questionnaire [Time frame: At inclusion]
  • Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - GAD7 [Time frame: At inclusion]
  • Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - PHQ9 questionnaire [Time frame: At inclusion]
  • Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - PSQI questionnaire [Time frame: At inclusion]
  • Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - EQ-5D-5L questionnaire [Time frame: At inclusion]

Eligibility criteria

Inclusion criteria

  • Patients with NMDAR encephalitis
  • Age ≥ 18 years old
  • Patient affiliated to a social security system
  • No opposition from the patient
  • Access to an internet connection and a computer

Exclusion criteria

  • Patients whithout NMDAR encephalitis
  • Patient under guardianship or curatorship
  • Patient with neurological disorders pre-existing encephalitis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immune — Bron

Identifiers

NCT: NCT07158229 · 69HCL25_0541

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗