Long-term Impact of NMDAR Encephalitis, Level 3
ConditionNMDAR Autoimmune Encephalitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with NMDAR encephalitis
Age ≥ 18 years old
Patient affiliated to a social security system
No opposition from the patient
Disqualifiers
Patients whithout NMDAR encephalitis
Patient under guardianship or curatorship
Patient with neurological disorders pre-existing encephalitis
Trial population
Patients with anti-NMDA encephalitis aged over 18 years old and followed throughout France.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Other interventionComplete quality of life questionnaires focusing on fatigue, anxiety, depression, and sleep.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Anti-NMDAR encephalitis patients1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
At inclusion2
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)
Time frame
At inclusion3
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.
Time frame
At inclusion4
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.
Time frame
At inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospices Civils de Lyon
Lead sponsor
Charite University, Berlin, Germany
Collaborator
Source ClinicalTrials.gov