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OpenTrials
Completed

NCT Number: NCT06960811

Epileptic Psychoses and Their Link With Ictal Emotions and Consciousness

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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
  2. Ictal dysautonomy

    Time frame: From april 2025 to may 2025

    Measures of neurovegetatives signs during seizures based on ictal EKG, nurse examination (palor, ...)

  3. 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ASPAIC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 7, 2025
Registry last updated
Aug 6, 2025

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.

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