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
Location status: Recruiting
Recruiting
NCT Number: NCT07158229
Long-term Impact of NMDAR Encephalitis, Level 3
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
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
- 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
Treatment and study plan
questionnaires
OtherComplete quality of life questionnaires focusing on fatigue, anxiety, depression, and sleep.
Primary outcomes
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Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PREMS questionnaires - AEPREM questionnaire
Time frame: At inclusion
AEPREM questionnaire (stands for "evaluation of experience in healthcare facilities and medical teams" in french)
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Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PREMS questionnaire - AESOC
Time frame: At inclusion
AESOC questionnaire ( stands for "questionnaire on clinical symptoms and perception of the disease" in french)
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Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaires - FSS questionnaire
Time frame: At inclusion
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.
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Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - GAD7
Time frame: At inclusion
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.
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Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - PHQ9 questionnaire
Time frame: At inclusion
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.
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Analysis of cognitive assessments and psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease - PROMS questionnaire - PSQI questionnaire
Time frame: At inclusion
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
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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
Time frame: At inclusion
EQ-5D-5L questionnaire (stands for "EuroQol-5-Dimension") assesses quality of life in patients.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Hospices Civils de Lyon
Other
Collaborators
- Charite University, Berlin, Germany
Registry information
Official study title
Social and Psychological Long-term Impact of NMDA Receptor Encephalitis, Level 3
Acronym: SAPIENCE 3
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Sep 5, 2025
- Registry last updated
- Feb 17, 2026
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.
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