Long-term Impact of NMDAR Encephalitis

Recruiting

• Conditions: Autoimmune Encephalitis

• Registration Number: NCT06609044
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

This study will help improve the management of patients with anti-NMDAR encephalitis :

* By providing the first assessment of long-term cognitive, psychological and social consequences

* By characterizing the patient's journey through the disease

* By developing a standardized neuropsychological assessment which will improve the assessment of the patient in the post-acute phase As well as improving patient care in the long term through the drafting of specific medical recommendations.

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-23
• Study Start: 2024-12-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-12-17
• Study Completion: 2025-12-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with NMDAR encephalitis
• Age ≥ 18 years old
• Patient affiliated to a social security system
• No opposition from the patient

Exclusion Criteria

• Patients whithout NMDAR encephalitis
• Age < 18 years old
• Patient under guardianship or curatorship
• Patient with neurological disorders pre-existing encephalitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease.	50 MINUTES	Neuropsychological Questionnaires : * RAVLT questionnaire (no score); * EMPAN questionnaire (no score)
Analysis of cognitive assessments of patients with anti-NMDAR encephalitis after the acute phase of the disease.	40 MINUTES	Score of PROMs questionnaires : * FSS (score : /63); * HADS (score : /42); * EQ5D5L (score : /100); * BDI-II (no score ); * MMQ (no score); * PSQI (no score)
Patient's experience of the disease	1 Year	Score of Clinical questionnaire about patient's experience of the disease

Trial Locations

Locations (1)

Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER; 🇫🇷 Bron, France