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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Psychological Long-term Impact of NMDA Receptor Encephalitis, Level 3
- ClinicalTrials.gov ID
- NCT07158229
- Acronym / sponsor ID
- SAPIENCE 3 / 69HCL25_0541
- Conditions
- NMDAR Autoimmune Encephalitis
- Keywords
- NMDAR encephalitis, psychosocial impact
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-NMDAR encephalitis patients | – | Other: QuestionnairesPatients over 18 years old with NMDAR encephalitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anti-NMDA encephalitis aged over 18 years old and followed throughout France.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients whithout NMDAR encephalitis
- Patient under guardianship or curatorship
- Patient with neurological disorders pre-existing encephalitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesComplete quality of life questionnaires focusing on fatigue, anxiety, depression, and sleep. | Other | Anti-NMDAR encephalitis patients |
Primary outcome
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)
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)
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.
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.
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NMDAR Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérôme HONNORAT, Pr (0472357806 ext. +33, jerome.honnorat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.