Clinical trial NCT06960811: Epileptic Psychoses and Their Link With Ictal Emotions and Consciousness
Official title: Study of Association Between Ictal Affective Symptoms, Ictal Consciousness Level and the Presence of Comorbid Epileptic Psychoses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy With Partial Onset Seizures With or Without Secondary Generalization
Psychoses
Epilepsy, Generalized
Keywords: psychoses of epilepsy
postictal psychosis
interictal psychosis
epilepsy
clinical research
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a certain diagnosis of epilepsy, based on a video-EEG monitoring, hospitalized in tertiary center for epilepsy care, and who have a psychiatric evaluation specialized in patients with epilepsy.

There are limited exclusion criteria to ensure the best representation of patients with epilepsy

Brief summary: Background :

Psychiatric comorbidities are common in epilepsy, affecting 50 to 70% of patients, especially when the epilepsy is focal and drug-resistant. Among these comorbidities, psychotic disorders (involving hallucinations and delusions) affect 8% of patients - that is, eight times more frequently than in the general population. Currently, the links between epilepsy and psychotic disorders are poorly understood and often overlooked by physicians, which impacts the mental health care of patients with epilepsy and leads to underdiagnosis.

The aim of this research is to determine whether there are differences in epileptic symptoms between patients with a psychotic comorbidity and those without.

Study design :

The main objective of this research is to better understand whether certain emotional epileptic symptoms are associated with a higher risk of developing psychotic symptoms.

The secondary objectives of this study are to investigate whether the level of consciousness during seizures is associated with a higher risk of developing psychotic symptoms.

To meet these objectives, the study will include patients who (1) have epilepsy, (2) were hospitalized in the video-EEG unit of the Neurology Department at Central Hospital for seizure recording, and (3) underwent a psychiatric evaluation in the context of epilepsy between January 1, 2016, and April 1, 2025.

The study will take place at the University Hospital Center (CHRU) of Nancy, in the Neurology Department, within the video-EEG unit led by Professor Louis Maillard. The research will involve comparing epileptic symptoms between the group of patients without psychosis and the group of patients with psychosis.

Data collection will cover the five days of video-EEG hospitalization, along with information from the psychiatric evaluation, for a total duration of approximately one week per year.

Information for participants:

As part of the routine medical care, data is collected in medical records to ensure appropriate follow-up. For the purposes of this research, data from the medical record will be collected.

No identifying information (such as name, initials, full date of birth, address, or social security number) will be collected.

No additional visits or examinations will be required. Patients will not be contacted or asked to provide any new information.


Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of epilepsy
* Patients hospitalized for at least 5 days for a video-EEG recording
* Patients with a psychiatric evaluation, conducted between 01/01/2016 and 04/01/2025.
* Adult patients able to express their opposition to the use of their data.

Exclusion Criteria:

* Absence of seizure recorded during the video-EEG

Primary outcomes:
measure: Ictal emotions
timeFrame: From april 2025 to may 2025
Secondary outcomes:
measure: Ictal consciousness
timeFrame: From april 2025 to may 2025
measure: Ictal dysautonomy
timeFrame: From april 2025 to may 2025
measure: Type of aura
timeFrame: From april 2025 to may 2025
Other outcomes:
Locations:
city: Nancy
country: France
facility: Center Hospital of Nancy
state: Lorraine
Study officials:
affiliation: Psychotherapeutic Center of Nancy
name: Coraline Hingray, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Tarrada A, Aron O, Vignal JP, Ertan D, Maillard L, Hingray C. Anticipatory anxiety of seizures is associated with ictal emotional distress and amygdala onset seizures. Epilepsia. 2022 May;63(5):1130-1140. doi: 10.1111/epi.17215. Epub 2022 Mar 20.
citation: Tarrada A, Hingray C, Sachdev P, Le Thien MA, Kanemoto K, de Toffol B. Epileptic psychoses are underrecognized by French neurologists and psychiatrists. Epilepsy Behav. 2019 Nov;100(Pt A):106528. doi: 10.1016/j.yebeh.2019.106528. Epub 2019 Oct 24.
citation: Hesdorffer DC, Ishihara L, Mynepalli L, Webb DJ, Weil J, Hauser WA. Epilepsy, suicidality, and psychiatric disorders: a bidirectional association. Ann Neurol. 2012 Aug;72(2):184-91. doi: 10.1002/ana.23601. Epub 2012 Aug 7.