Epilepsy With Partial Onset Seizures With or Without Secondary GeneralizationASPAICNCT06960811
Epileptic Psychoses and Their Link With Ictal Emotions and Consciousness
An observational study of Epilepsy With Partial Onset Seizures With or Without Secondary Generalization and Psychoses, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy With Partial Onset Seizures With or Without Secondary Generalization, Psychoses, Epilepsy, Generalized
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2025to 5 Aug 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Absence of seizure recorded during the video-EEG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- 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
- Medical subject headings
- Psychotic Disorders, Epilepsy, Generalized, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Ictal emotions
Clinician-assessment of ictal affective symptomatology (facial, verbal, and motor expression), based on a the visualization of an usual seizure recorded in video-EEG.
Measured: From april 2025 to may 2025
Secondary outcomes (3)
Ictal consciousness
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
Measured: From april 2025 to may 2025
Ictal dysautonomy
Measures of neurovegetatives signs during seizures based on ictal EKG, nurse examination (palor, ...)
Measured: From april 2025 to may 2025
Type of aura
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
Measured: From april 2025 to may 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start2 May 2025
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epilepsy With Partial Onset Seizures With or Without Secondary GeneralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TARRADA Alexis, Central Hospital, Nancy, France
- Investigators
- Coraline Hingray, MD, PhD, Study director, Psychotherapeutic Center of Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960811
- Sponsor's protocol ID
- 2025PI050-601
- Acronym
- ASPAIC
- Status last verified
- Aug 2025
- First submitted
- 29 Apr 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35263805Tarrada 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.
PubMed 31654941Hesdorffer 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.
PubMed 22887468