Long-term Impact of NMDAR Encephalitis, Level 3

Not yet recruiting

• Conditions: NMDAR Autoimmune Encephalitis

• Registration Number: NCT07158229
• 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

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PREMS questionnaires - AEPREM questionnaire	At inclusion	AEPREM questionnaire (stands for "evaluation of experience in healthcare facilities and medical teams" in french)
Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PREMS questionnaire - AESOC	At inclusion	AESOC questionnaire ( stands for "questionnaire on clinical symptoms and perception of the disease" in french)
Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaires - FSS questionnaire	At inclusion	FSS questionnaire (stands for "fatigue severity scale") assesses fatigue in patients
Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - GAD7	At inclusion	GAD7 questionnaire (stands for "Generalized Anxiety Disorder 7") assesses anxiety in patients.
Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - PHQ9 questionnaire	At inclusion	PHQ9 questionnaire (stands for "Patient Health Questionnaire-9") assesses depression in patients
Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - PSQI questionnaire	At inclusion	PSQI questionnaire (stands for "Pittsburgh Sleep Quality Index") assesses sleep in patients.
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	At inclusion	EQ-5D-5L questionnaire (stands for "EuroQol-5-Dimension") assesses quality of life in patients.

Trial Locations

Locations (1)

Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER - Groupement hospitalier Est - Hospices civiles de Lyon; 🇫🇷 Bron, France