Long-term Impact of NMDAR Encephalitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autoimmune Encephalitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER

Bron, 69500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease.

Time frame: 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.

Time frame: 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

Time frame: 1 Year

Score of Clinical questionnaire about patient's experience of the disease

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Social and Psychological Long-term Impact of NMDA Receptor Encephalitis

Acronym: SAPIENCE2

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 23, 2024
Registry last updated: Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed