Trials / Unknown
UnknownNCT03464370
Evaluation of Stress Sensitivity and Hyperemotivity in Epilepsy Compared to and a Group of Healthy Volunteers
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.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- University Hospital, Toulouse · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-03-08
- Primary completion
- 2020-03-01
- Completion
- 2020-03-01
- First posted
- 2018-03-14
- Last updated
- 2018-07-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03464370. Inclusion in this directory is not an endorsement.