EpilepsySTELLANCT03464370
Evaluation of Stress Sensitivity and Hyperemotivity in Epilepsy Compared to and a Group of Healthy Volunteers
A study testing Measure of emotional stressors in people with Epilepsy, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Measure of emotional stressors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any mental disorder.
- Any diabetes
- Beta-blockers
- Neuroleptics
- Any neurologic diseases for the healthy volunteers.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Marie DENUELLE, MD, 05 61 77 79 24 ext. 33, denuelle.m@chu-toulouse.fr
Isabelle Olivier, PhD, 5 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
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.
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.
Read the 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
- Epilepsy
- Being tested
- Measure of emotional stressors
- Keywords
- amygdala enlargement, temporal lobe epilepsy, stress, attentional bias, anxiety, depression, PTSD
- Medical subject headings
- Epilepsy, Epilepsy, Temporal Lobe, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of emotional stressorsOther
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
| Study group | Role | What they receive |
|---|---|---|
| TLE-AE Group | Experimental | 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. Receives: Other: Measure of emotional stressors |
| Non AE epileptic Group | Active comparator | 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. Receives: Other: Measure of emotional stressors |
| Extra-temporal epilepsy Group | Active comparator | 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. Receives: Other: Measure of emotional stressors |
| Healthy volunteers Group | Active comparator | 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 Receives: Other: Measure of emotional stressors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (9)
Score of The Emotional Stroop tasks
The score of the congruency index in the Emotional Stroop tasks : evaluate the attention bias towards threatening information
Measured: 30 minutes
Score of The congruency index
The score of the congruency index in the modified probe detection tasks : evaluate the attention bias towards threatening information
Measured: 30 minutes
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
Measured: 30 minutes
Score of The Perceived Stress Scale 10
The score of the Perceived Stress Scale 10 : evaluate the perception of stress
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
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
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start8 Mar 2018
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This pilot study is prospective, monocentric, epidemiologic, case control
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie DENUELLE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464370
- Sponsor's protocol ID
- RC31/17/0276
- Other IDs
- 2017-A02853-50
- Acronym
- STELLA
- Status last verified
- Jul 2018
- First submitted
- 7 Mar 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03464370
- Acronym / sponsor ID
- STELLA / RC31/17/0276
- Conditions
- Epilepsy
- Keywords
- amygdala enlargement, temporal lobe epilepsy, stress, attentional bias, anxiety, depression, PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This pilot study is prospective, monocentric, epidemiologic, case control
| Arm | Type | Receives |
|---|---|---|
| TLE-AE Group | Experimental | Other: Measure of emotional stressors30 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 comparator | Other: Measure of emotional stressors30 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 comparator | Other: Measure of emotional stressors30 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 comparator | Other: Measure of emotional stressors30 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Any mental disorder.
- Any diabetes
- Beta-blockers
- Neuroleptics
- Any neurologic diseases for the healthy volunteers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of emotional stressorsFor 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 | Other | Extra-temporal epilepsy Group, Healthy volunteers Group, Non AE epileptic Group, TLE-AE Group |
Primary outcome
Score on the scale of emotional seizure precipitant the outbreak
Time frame: 30 minutes
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.
9 secondary outcomes
Score of The Emotional Stroop tasks
Time frame: 30 minutes
Score of The congruency index
Time frame: 30 minutes
Score of the Scale measures during the movie tasks
Time frame: 30 minutes
Score of The Perceived Stress Scale 10
Time frame: 30 minutes
Score of The Tyrer's brief Scale for Anxiety (BAS)
Time frame: 30 minutes
Score of The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).
Time frame: 30 minutes
Score of The Affect intensity measure (AIM)
Time frame: 30 minutes
Score of The Clinical-administered PTSD Scale (CAPS)
Time frame: 30 minutes
Score of The Post-Traumatic Checklist Scale (PCLS).
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie DENUELLE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of emotional stressors in people with Epilepsy, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie DENUELLE, MD (5 61 77 79 24 ext. 33, denuelle.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the scale of emotional seizure precipitant the outbreak (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.