Clinical trial NCT05393518: Electroclinical Correlation of Anxiety
Official title: Electroclinical Correlation of Anxiety, Evidences From Intracerebral Recordings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorder
Generalized Anxiety Disorder
Drug Resistant Epilepsy
Keywords: Focal epilepsy
Generalized Anxiety Disorder
Intracranial recordings
Stereoenectroencephalography
Coherence
Networks
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-05-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Anxiety disorders have the highest prevalence among mental disorders and cause considerable individual and financial costs. Current treatments do not relieve mental suffering of many patients. Understanding neurobiological mechanisms involved in pathological anxiety is a major scientific challenge.

Detailed description: Functional imaging work has made it possible to identify the brain regions involved in anxiety disorders but is insufficient to study the pathophysiological mechanisms that cause anxiety symptoms. Brain regions involved in anxiety disorders are located deep in the human brain, and their electrophysiological study requires invasive recording methods.

Intracerebral electroencephalographic recordings (stereoelectroencephalography - sEEG) made for care in hospital before surgery in patients with drug-resistant epilepsy, offer this unique opportunity. Indeed, the brain regions involved in anxiety are among the structures registered to delimit the epilepticogenic zone, and 20% of patients with drug-resistant epilepsy suffer from an anxiety disorder.

This study propose to compare 10 patients suffering from drug-resistant epilepsy and generalized anxiety disorders (GAD), explored by intracranial sEEG, and 10 patients suffering from drug-resistant epilepsy without GAD ("controls"),explored by sEEG.

During sEEG patient will be proposed to undergo a custom-made behavioral task design to allow clinically-relevant anxiogenic exposure.

Patients will so be exposed to anxiety scenarios, while intracerebral sEEG, physiological stress parameters and the level of anxiety experienced will be monitored.

Electrophysiological parameters will be compared and correlated with clinical characteristics of the population and outcomes of the task.

Eligibility criteria: Inclusion Criteria:

* Man or woman
* Aged 18 to 65;
* With drug-resistant epilepsy
* Benefiting from a phase II pre-surgical assessment with intracerebral electrophysiological exploration by stereo-EEG
* Meeting the DSM-5 diagnostic criteria for generalized anxiety disorder ("pathological" population) or not meeting the DSM-5 diagnostic criteria for generalized anxiety disorder ("control" population)
* WAIS IV full scale IQ \> 75
* Affiliate or beneficiary of a social security scheme
* Giving free, informed consent in writing and signed by the participant and the investigator

Exclusion Criteria:

* Being unable to give personal consent
* Be subject to a measure of legal protection (curatorship, guardianship) or placed under judicial protection;
* Suffer from a chronic delusional disorder (eg: schizophrenia);
* Have a high risk of suicide assessed using the corresponding section of the structured psychiatric interview called "Mini International Neuropsychiatric Interview" (M.I.N.I. 7.0);
* Being pregnant or breastfeeding
* Have severe and / or decompensated somatic illness other than drug-resistant epilepsy

Primary outcomes:
measure: Change in neuronal coherence in the frontolimbic network
timeFrame: Inclusion (Day 1)
Secondary outcomes:
measure: Generalized Anxiety Disorders (GAD) severity score at The Penn State Worry Questionnaire (PSWQ)
timeFrame: Inclusion (Day 1)
measure: SEEG power spectrum changes
timeFrame: Inclusion (Day 1)
measure: Wechsler adult intelligent scale Score (WAIS-R full scale IQ)
timeFrame: Inclusion (Day 1)
measure: Auditory and visual memory index (MEM IV)
timeFrame: Inclusion (Day 1)
measure: Quality of life scale applied to epilepsy (QOLI-E 31)
timeFrame: Inclusion (Day 1)
measure: Neurological Disorders Depression Inventoiry for Epilepsy (NDDI-E)
timeFrame: Inclusion (Day 1)
measure: Generalized Anxiety Disorder 7- items (GAD-7)
timeFrame: Inclusion (Day 1)
measure: Beck Depression Inventory (BDI)
timeFrame: Inclusion (Day 1)
measure: Montgomery and Asberg Depression Rating Scale (MADRS) Score
timeFrame: Inclusion (Day 1)
measure: State Anxiety Inventory (STAI)
timeFrame: Inclusion (Day 1)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Inclusion (Day 1)
measure: Hamilton Antiety rating Scale (HAM-A) Score
timeFrame: Inclusion (Day 1)
measure: Analog Visual Scale (EVA) Anxiety score
timeFrame: Inclusion (Day 1)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Jérôme Aupy, Dr
role: PRINCIPAL_INVESTIGATOR
References: