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

Epilepsy Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03464370
• Other study ID #: RC31/17/0276
• Secondary ID: 2017-A02853-50
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: March 2020

Study information

• Verified date: July 2018
• Source: University Hospital, Toulouse
• Contact: Marie DENUELLE, MD
• Phone: 5 61 77 79 24
• Email: denuelle.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

Other:
• Measure of emotional stressors
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

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Score of The Emotional Stroop tasks	The score of the congruency index in the Emotional Stroop tasks : evaluate the attention bias towards threatening information	30 minutes
Secondary	Score of The congruency index	The score of the congruency index in the modified probe detection tasks : evaluate the attention bias towards threatening information	30 minutes
Secondary	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	30 minutes
Secondary	Score of The Perceived Stress Scale 10	The score of the Perceived Stress Scale 10 : evaluate the perception of stress	30 minutes
Secondary	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.	30 minutes
Secondary	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.	30 minutes
Secondary	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	30 minutes
Secondary	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.	30 minutes
Secondary	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.	30 minutes