Long-term Impact of NMDAR Encephalitis

NCT06609044 | Completed

• 2 other identifiers: 69HCL24_07932024-A01958-39
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Encephalitis

Keywords

NMDAR encephalitis; psychosocial impact

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Anti-NMDAR encephalitis patients.

Patients over 18 years old with NMDAR encephalitis.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

Related Publications (1)

• 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.

  PMID: 39242986 RESULT

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 23, 2024
• Study Start: December 16, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)