Evaluation of Stress Sensitivity and Hyperemotivity in Epilepsy Compared to and a Group of Healthy Volunteers
STELLA
2 other identifiers
interventional
120
1 country
1
Brief Summary
Recently, a possible subtype of temporal lobe epilepsy (TLE) has been proposed: this subtype presents ipsilateral amygdala enlargement (AE) without any other lesion. However, little is known about its clinical and psychiatric phenotype. The amygdala seems to play a major role in stress related disorders (including perception of stress). The hypothesis in this study is that patients with TLE-AE more frequently report emotional distress as a seizure-precipitating factor than any other epileptic patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2018
CompletedStudy Start
First participant enrolled
March 8, 2018
CompletedFirst Posted
Study publicly available on registry
March 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJuly 20, 2018
July 1, 2018
2 years
March 7, 2018
July 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on the scale of emotional seizure precipitant the outbreak
It is a hetero-questionnaire, subjectively measuring the sensitivity of an epileptic patient to the stressors of daily life that may trigger or promote the onset of their seizures.
30 minutes
Secondary Outcomes (9)
Score of The Emotional Stroop tasks
30 minutes
Score of The congruency index
30 minutes
Score of the Scale measures during the movie tasks
30 minutes
Score of The Perceived Stress Scale 10
30 minutes
Score of The Tyrer's brief Scale for Anxiety (BAS)
30 minutes
- +4 more secondary outcomes
Study Arms (4)
TLE-AE Group
EXPERIMENTAL30 subjects Age between 18 and 65 case-control with 2 witnesses per sex and age matched cases (within 5 years) for the evaluation of the primary endpoint. For the secondary endpoints, 3 controls will be matched for each case on gender and age (within 5 years) Measure of emotional stressors then evaluate the traumatic events and to date them with respect to the beginning of epilepsy in different populations of epileptics.
Non AE epileptic Group
ACTIVE COMPARATOR30 subjects Age between 18 and 65 case-control with 2 witnesses per sex and age matched cases (within 5 years) for the evaluation of the primary endpoint. For the secondary endpoints, 3 controls will be matched for each case on gender and age (within 5 years) Measure of emotional stressors then evaluate the traumatic events and to date them with respect to the beginning of epilepsy in different populations of epileptics.
Extra-temporal epilepsy Group
ACTIVE COMPARATOR30 subjects Age between 18 and 65 case-control with 2 witnesses per sex and age matched cases (within 5 years) for the evaluation of the primary endpoint. For the secondary endpoints, 3 controls will be matched for each case on gender and age (within 5 years) Measure of emotional stressors and then evaluate the traumatic events and to date them with respect to the beginning of epilepsy in different populations of epileptics.
Healthy volunteers Group
ACTIVE COMPARATOR30 subjects Age between 18 and 65 case-control with 2 witnesses per sex and age matched cases (within 5 years) for the evaluation of the primary endpoint. For the secondary endpoints, 3 controls will be matched for each case on gender and age (within 5 years) Measure of emotional stressors
Interventions
For the Epileptic Group * Rapid interrogation, completing the clinical data * A scale of impact of the precipitating factors of crises * An emotional Stroop * A task of detecting emotional targets against threatening information * A measure of the perception of emotions using film clips * A scale of measurement of perceived stress * The transfer of psychiatric scales For the healthy volunteers group : * A rapid interrogation, gathering the possible medical history, the level of studies, the manual laterality * An emotional Stroop * A task of detecting emotional targets against threatening information * A scale of measurement of perceived stress * A measure of the perception of emotions using film clips * A rapid neuropsychological assessment
Eligibility Criteria
You may qualify if:
- \- For all epileptic patients: Age between 18 and 65. Epilepsy (TLE or not) followed by an epileptologist.
- \- For TLE-AE: An AE identified on the MRI by an expert neuroradiologist. MRI must be less than one year.
- \- For non AE epileptic patients: No AE reported in the MRI by an expert neuroradiologist.
You may not qualify if:
- Any mental disorder.
- Any diabetes
- Beta-blockers
- Neuroleptics
- Any neurologic diseases for the healthy volunteers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Toulouse
Toulouse, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie DENUELLE, MD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 14, 2018
Study Start
March 8, 2018
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
July 20, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share