- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06960811
- Original Trial
Epileptic Psychoses and Their Link With Ictal Emotions and Consciousness (ASPAIC)
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
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lorraine
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Nancy, Lorraine, France, 54000
- Center Hospital of Nancy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ictal emotions
Time Frame: From april 2025 to may 2025
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Clinician-assessment of ictal affective symptomatology (facial, verbal, and motor expression), based on a the visualization of an usual seizure recorded in video-EEG.
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From april 2025 to may 2025
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ictal dysautonomy
Time Frame: From april 2025 to may 2025
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Measures of neurovegetatives signs during seizures based on ictal EKG, nurse examination (palor, ...)
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From april 2025 to may 2025
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Type of aura
Time Frame: From april 2025 to may 2025
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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
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From april 2025 to may 2025
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Ictal consciousness
Time Frame: From april 2025 to may 2025
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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
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From april 2025 to may 2025
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Coraline Hingray, MD, PhD, Psychotherapeutic Center of Nancy
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025PI050-601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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