Skip to main content
OpenTrials
Completed

NCT Number: NCT05954468

Psycho-social Impact of Anti-NMDAR Encephalitis

NMDA receptor encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms, but a typically good functional neurological outcome. The majority of patients experience long-term cognitive, psychological and social impairments that have significant consequences for their well-being and quality of life. However, as the disease was only recently discovered (Dalmau and al. Annals of neurology, 2007), this psycho-social impact has not been studied systematically and the resulting consequences for patients are not adequately appreciated.

The proposed study aims at characterizing the cognitive and psycho-social long-term consequences of this rare disease. Our main hypothesis is that NMDAR encephalitis has a persistent and clinically relevant impact on the patients' long-term cognitive, psychological and social well-being. Furthermore, we hypothesize that longterm subjective outcomes depend on both internal and external factors, such as acute disease course, access to post-acute care, caregiver support, personal coping strategies, or access to health education resources and peer group support.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Hôpital neurologique Pierre Wertheimer

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with anti-NMDAR encephalitis
  • Year ≥ 18 ans
  • Patients affiliated to the social security scheme

Exclusion criteria

  • Patients with no anti-NMDAR encephalitis
  • Minor patient
  • Patient under guardianship or curatorship
  • Patient with preexisting neurological symptoms

Treatment and study plan

standardized and validated surveys

Other

To evaluate the cognitive and psycho-social long term impact of a NMDAR encephalitis, we will collect the data using specific interview assessments such as the PROMS (Patient-reported Outcome Measures Information System) and PREMS (Patient-reported experiences measures) as well as we will check the cognitive performance in order to combine the expertise from clinical neurology, social & health psychology

Primary outcomes

  1. Cognitive and psycho-social analyses of patients with NMDAR encephalitis.

    Time frame: At study completion in an average of 12 months

    The analyze will focus on the post-acute phase of the disease.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SAPIENCE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2023
Registry last updated
Sep 19, 2024

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.