Epileptic Psychoses and Their Link With Ictal Emotions and Consciousness (ASPAIC)

August 5, 2025 updated by: TARRADA Alexis, Central Hospital, Nancy, France

Study of Association Between Ictal Affective Symptoms, Ictal Consciousness Level and the Presence of Comorbid Epileptic Psychoses

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lorraine
      • Nancy, Lorraine, France, 54000
        • Center Hospital of Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PEP +
Patients diagnosed with epilepsy based on video-EEG recording of seizures and with a psychotic comorbidity according to a standardized psychiatric assessment specialized in Epi-Psy
PEP -
Patients diagnosed with epilepsy based on video-EEG recording of seizures and without psychotic comorbidity according to a standardized psychiatric assessment specialized in Epi-Psy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ictal emotions
Time Frame: From april 2025 to may 2025
Clinician-assessment of ictal affective symptomatology (facial, verbal, and motor expression), based on a the visualization of an usual seizure recorded in video-EEG.
From april 2025 to may 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ictal dysautonomy
Time Frame: From april 2025 to may 2025
Measures of neurovegetatives signs during seizures based on ictal EKG, nurse examination (palor, ...)
From april 2025 to may 2025
Type of aura
Time Frame: From april 2025 to may 2025
Assessment of the type of aura based on the patients description of their seizure and on the video-EEG recording at the beginning of the seizure
From april 2025 to may 2025
Ictal consciousness
Time Frame: From april 2025 to may 2025

Clinician-rating of the Consciousness Seizure Scale (CSS) validated for the assessment of level of consciousness during a seizure. Scores on the CSS range from 0 to 9, which can be interpreted as follows

  • 0 or 1 meaning a profound alteration of consciousness during seizure
  • 2 to 5 meaning an intermediate alteration of consciousness during seizure
  • 6 and more meaning a relatively preserved consciousness during seizure
From april 2025 to may 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Coraline Hingray, MD, PhD, Psychotherapeutic Center of Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Actual)

August 5, 2025

Study Completion (Actual)

August 5, 2025

Study Registration Dates

First Submitted

April 29, 2025

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 7, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy, Generalized

3
Subscribe