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Evaluation of Stress Sensitivity and Hyperemotivity in Epilepsy Compared to and a Group of Healthy Volunteers (STELLA)

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measure of emotional stressors
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy focused on measuring amygdala enlargement, temporal lobe epilepsy, stress, attentional bias, anxiety, depression, PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • Any mental disorder.
  • Any diabetes
  • Beta-blockers
  • Neuroleptics
  • Any neurologic diseases for the healthy volunteers.

Sites / Locations

  • University Hospital ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

TLE-AE Group

Non AE epileptic Group

Extra-temporal epilepsy Group

Healthy volunteers Group

Arm Description

30 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.

30 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.

30 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.

30 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Score of The Emotional Stroop tasks
The score of the congruency index in the Emotional Stroop tasks : evaluate the attention bias towards threatening information
Score of The congruency index
The score of the congruency index in the modified probe detection tasks : evaluate the attention bias towards threatening information
Score of the Scale measures during the movie tasks
The score of scale (valence, arousal, avoidance) in the movie tasks : evaluate the emotional experience using film clips inducing emotion
Score of The Perceived Stress Scale 10
The score of the Perceived Stress Scale 10 : evaluate the perception of stress
Score of The Tyrer's brief Scale for Anxiety (BAS)
The score of the Tyrer's brief Scale for Anxiety (BAS) will evaluate the existence of an anxiety syndrome.This scale is validated, it is a hetero-questionnaire to evaluate anxiety, in 10 items, sides from 0 to 6.
Score of The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).
The score of the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) : the existence of a depressive syndrome.
Score of The Affect intensity measure (AIM)
The score of the Affect intensity measure (AIM) : the multidimensional assessment of thymic states (MAThyS) : evaluate the emotional lability
Score of The Clinical-administered PTSD Scale (CAPS)
The clinical post-traumatic stress disorder scale (CAPS: Clinical-administered PTSD Scale) is the gold standard for diagnosing Post-Traumatic Stress Disorder (PTSD). To pass the entire questionnaire, it takes about sixty minutes. For the scoring list of milestones, it takes about 5 minutes. The CAPS is the only questionnaire that provides information on both the frequency and intensity of symptoms, with specific behavioral anchor points.
Score of The Post-Traumatic Checklist Scale (PCLS).
The Post-Traumatic Checklist Scale (PCLS) is a simple self-questionnaire of about 10 minutes measuring the three main sub-syndromes of post-traumatic stress disorder: repetition (items 1 to 5), avoidance ( items 6 to 12) and neurovegetative hyperactivity (items 13 to 17). The scale is composed of 17 items, rated from 1 to 5. There is a cut-off at ≥ 45 to diagnose post-traumatic stress disorder. The validity of the French translation has been verified.

Full Information

First Posted
March 7, 2018
Last Updated
July 18, 2018
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03464370
Brief Title
Evaluation of Stress Sensitivity and Hyperemotivity in Epilepsy Compared to and a Group of Healthy Volunteers
Acronym
STELLA
Official Title
Evaluation of Stress Sensitivity and Hyperemotivity in Temporal Lobe Epilepsy With Enlarged Amygdala Compared to Epilepsy Without Enlarged Amygdala (Temporal and Extra-temporal) and a Group of Healthy Volunteers: Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
TLE-AE could concern 16 to 64 % of the TLE with "negative" MRI (Beh et al., 2016). TLE-AE patients may suffer from anxiety and depression (Lv et al, 2014). In clinical practice, it has been also identified an emotional vulnerability in these patients, as they report more frequently a high sensitivity to emotional distress than other epileptic patients. They also report a change in their affect intensity or a hyperemotivity, which appeared at the onset of their epilepsy. Lanteaume et al. have linked some TLE with an increased emotional vulnerability (Emo-TLE): these TLE patients reported stress factors precipitating their seizures. They found that the Emo-TLE group was characterized by an attentional bias toward threatening stimuli versus neutral stimuli, and that this bias was noticed neither in the TLE group without emotional vulnerability nor in healthy volunteers. But they did not study amygdala structure in each group.In the large database of the Toulouse University Hospital, screening was done to retrospectively collect TLE patients with AE identified on MRI. This large database has served to establish a reading grid in order to help the visual identification of an AE.The investigators propose to these patients them a series of validated scales to test: The impact of emotional stress factors for precipitating seizures The perception of stress (PSS-10). Psychiatric comorbidities (anxiety, depression, post-traumatic stress disorder, emotional lability…). The study also propose cognitive tasks to search for an attentional bias towards threatening stimuli (Emotional Stroop and modified probe test). After this, the study will assess their emotional subjective responses (valence, arousal, avoidance) through a task during which they are presented with short movies that elicit six different emotions. At the same time, the measure of the variations of their neurovegetative system in terms of blood pressure, heart rate variability and electrodermal skin conductance variability will be done. For each TLE-AE patient, additional healthy controls will be matched (2 for testing the primary outcome, 3 for the secondary outcomes).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
amygdala enlargement, temporal lobe epilepsy, stress, attentional bias, anxiety, depression, PTSD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This pilot study is prospective, monocentric, epidemiologic, case control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TLE-AE Group
Arm Type
Experimental
Arm Description
30 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.
Arm Title
Non AE epileptic Group
Arm Type
Active Comparator
Arm Description
30 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.
Arm Title
Extra-temporal epilepsy Group
Arm Type
Active Comparator
Arm Description
30 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.
Arm Title
Healthy volunteers Group
Arm Type
Active Comparator
Arm Description
30 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
Intervention Type
Other
Intervention Name(s)
Measure of emotional stressors
Intervention Description
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
Primary Outcome Measure Information:
Title
Score on the scale of emotional seizure precipitant the outbreak
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Score of The Emotional Stroop tasks
Description
The score of the congruency index in the Emotional Stroop tasks : evaluate the attention bias towards threatening information
Time Frame
30 minutes
Title
Score of The congruency index
Description
The score of the congruency index in the modified probe detection tasks : evaluate the attention bias towards threatening information
Time Frame
30 minutes
Title
Score of the Scale measures during the movie tasks
Description
The score of scale (valence, arousal, avoidance) in the movie tasks : evaluate the emotional experience using film clips inducing emotion
Time Frame
30 minutes
Title
Score of The Perceived Stress Scale 10
Description
The score of the Perceived Stress Scale 10 : evaluate the perception of stress
Time Frame
30 minutes
Title
Score of The Tyrer's brief Scale for Anxiety (BAS)
Description
The score of the Tyrer's brief Scale for Anxiety (BAS) will evaluate the existence of an anxiety syndrome.This scale is validated, it is a hetero-questionnaire to evaluate anxiety, in 10 items, sides from 0 to 6.
Time Frame
30 minutes
Title
Score of The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).
Description
The score of the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) : the existence of a depressive syndrome.
Time Frame
30 minutes
Title
Score of The Affect intensity measure (AIM)
Description
The score of the Affect intensity measure (AIM) : the multidimensional assessment of thymic states (MAThyS) : evaluate the emotional lability
Time Frame
30 minutes
Title
Score of The Clinical-administered PTSD Scale (CAPS)
Description
The clinical post-traumatic stress disorder scale (CAPS: Clinical-administered PTSD Scale) is the gold standard for diagnosing Post-Traumatic Stress Disorder (PTSD). To pass the entire questionnaire, it takes about sixty minutes. For the scoring list of milestones, it takes about 5 minutes. The CAPS is the only questionnaire that provides information on both the frequency and intensity of symptoms, with specific behavioral anchor points.
Time Frame
30 minutes
Title
Score of The Post-Traumatic Checklist Scale (PCLS).
Description
The Post-Traumatic Checklist Scale (PCLS) is a simple self-questionnaire of about 10 minutes measuring the three main sub-syndromes of post-traumatic stress disorder: repetition (items 1 to 5), avoidance ( items 6 to 12) and neurovegetative hyperactivity (items 13 to 17). The scale is composed of 17 items, rated from 1 to 5. There is a cut-off at ≥ 45 to diagnose post-traumatic stress disorder. The validity of the French translation has been verified.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: Any mental disorder. Any diabetes Beta-blockers Neuroleptics Any neurologic diseases for the healthy volunteers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie DENUELLE, MD
Phone
5 61 77 79 24
Ext
33
Email
denuelle.m@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Olivier, PhD
Phone
5 61 77 70 51
Ext
33
Email
olivier.i@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie DENUELLE, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie DENUELLE, MD
Phone
05 61 77 79 24
Ext
33
Email
denuelle.m@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Isabelle Olivier, PhD
Phone
5 61 77 70 51
Ext
33
Email
olivier.i@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Stress Sensitivity and Hyperemotivity in Epilepsy Compared to and a Group of Healthy Volunteers

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