Long-term Impact of NMDAR Encephalitis, Level 3

NCT07158229 | Recruiting

• 1 other identifier: 69HCL25_0541
• Study Type: observational
• Target: 30
• 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

NMDAR Autoimmune Encephalitis

Keywords

NMDAR encephalitis; psychosocial impact

Outcome Measures

Primary Outcomes (7)

• Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PREMS questionnaires - AEPREM questionnaire

  AEPREM questionnaire (stands for "evaluation of experience in healthcare facilities and medical teams" in french)

  At inclusion

• Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PREMS questionnaire - AESOC

  AESOC questionnaire ( stands for "questionnaire on clinical symptoms and perception of the disease" in french)

  At inclusion

• Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaires - FSS questionnaire

  FSS questionnaire (stands for "fatigue severity scale") assesses fatigue in patients. Questionnaire is composed of 9 items graded on a scale from 1 to 7. Score varies from 9 to 63. The higher the score, the strongest the fatigue.

  At inclusion

• Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - GAD7

  GAD7 questionnaire (stands for "Generalized Anxiety Disorder 7") assesses anxiety in patients. Items are rated on a scale of 0 to 3. Score varies from 0 to 21. The recommended threshold for estimating generalised anxiety is 10. Thresholds: No anxiety: 0-4 points; Mild anxiety: 5-9 points; Moderate anxiety: 10-14 points; Severe anxiety: 15-21 points.

  At inclusion

• Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - PHQ9 questionnaire

  PHQ9 questionnaire (stands for "Patient Health Questionnaire-9") assesses depression in patients. Questionnaire is composed of 9 items each graded from 0 to 3. Score varies from 0 to 27. The higher the score, the more depressed is the patient.

  At inclusion

• Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - PSQI questionnaire

  PSQI questionnaire (stands for "Pittsburgh Sleep Quality Index") assesses sleep in patients. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties

  At inclusion

• 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

  EQ-5D-5L questionnaire (stands for "EuroQol-5-Dimension") assesses quality of life in patients.

  At inclusion

Study Arms (1)

Anti-NMDAR encephalitis patients

Patients over 18 years old with NMDAR encephalitis.

Other: Questionnaires

Interventions

Questionnaires OTHER

Complete quality of life questionnaires focusing on fatigue, anxiety, depression, and sleep.

Anti-NMDAR encephalitis patients

Eligibility Criteria

• Age: 18 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 throughout France.

You may qualify if:

• 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

You may not qualify if:

• Patients whithout NMDAR encephalitis
• Patient under guardianship or curatorship
• Patient with neurological disorders pre-existing encephalitis

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER - Groupement hospitalier Est - Hospices civiles de Lyon

Bron, 69500, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jérôme HONNORAT, Pr

CONTACT

0472357806; jerome.honnorat@chu-lyon.fr

Chloé BUTTARD

CONTACT

0426739377; ext-chloe.buttard@chu-lyon.fr

Study Design

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

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)