NMDAR Autoimmune EncephalitisSAPIENCE 3NCT07158229
Long-term Impact of NMDAR Encephalitis, Level 3
An observational study of NMDAR Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NMDAR Autoimmune Encephalitis
- What is being tested?
- Questionnaires
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2025to 21 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with anti-NMDA encephalitis aged over 18 years old and followed throughout France.
Who may be able to join
- 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
Who cannot join
- Patients whithout NMDAR encephalitis
- Patient under guardianship or curatorship
- Patient with neurological disorders pre-existing encephalitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER - Groupement hospitalier Est - Hospices civiles de Lyon
Bron, 69500
Jérôme HONNORAT, Pr, 0472357806 ext. +33, jerome.honnorat@chu-lyon.fr
About this study
Official title: Social and Psychological Long-term Impact of NMDA Receptor 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.
- Conditions
- NMDAR Autoimmune Encephalitis
- Being tested
- Questionnaires
- Keywords
- NMDAR encephalitis, psychosocial impact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Complete quality of life questionnaires focusing on fatigue, anxiety, depression, and sleep.
| Study group | Role | What they receive |
|---|---|---|
| Anti-NMDAR encephalitis patients | Patients over 18 years old with NMDAR encephalitis. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start21 Nov 2025
- Primary completion21 Nov 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMDAR Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158229
- Sponsor's protocol ID
- 69HCL25_0541
- Acronym
- SAPIENCE 3
- Status last verified
- Feb 2026
- First submitted
- 28 Aug 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No