Long-term Impact of NMDAR Encephalitis (SAPIENCE2)

Social and Psychological Long-term Impact of NMDA Receptor 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.

Study Overview

• Status: Completed
• Conditions: Autoimmune Encephalitis

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with anti-NMDA encephalitis aged over 18 years old and followed in Lyon.

We plan to include 30 patients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Anti-NMDAR encephalitis patients.; Patients over 18 years old with NMDAR encephalitis.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jérôme HONNORAT, MD, Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER - Groupement hospitalier Est - Hospices civiles de Lyon

Publications and helpful links

General Publications

• Boeken OJ, Heine J, Duda-Sikula M, Patricio V, Picard G, Buttard C, Benaiteau M, Mendes A, Howard F, Easton A, Kurpas D, Honnorat J, Dalmau J, Finke C. Assessment of long-term psychosocial outcomes in N-methyl-D-aspartate receptor encephalitis - the SAPIENCE study protocol. BMC Neurol. 2024 Sep 6;24(1):322. doi: 10.1186/s12883-024-03842-6.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: NMDAR encephalitis; psychosocial impact
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System
• Other Study ID Numbers: 69HCL24_0793; 2024-A01958-39 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No