Electroclinical Correlation of Anxiety (IRAnxNet)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Drug Resistant Epilepsy; Anxiety Disorder; Generalized Anxiety Disorder

Treatments: Behavioral: Anxiety-induced task; Behavioral: Neuropsychiatric assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05393518

CHUBX 2020/63

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Drug resistant epilepsy with GAD

Experimental group

Description:

Patients suffering from drug-resistant epilepsy and generalized anxiety disorders (GAD),explored by intracranial EEG (seteroelectroencephalography - SEEG) in Hospital

Treatment:

Behavioral: Anxiety-induced task

Behavioral: Neuropsychiatric assessment

Drug resistant epilepsy without GAD

Active Comparator group

Description:

Patients suffering from drug-resistant epilepsy without generalized anxiety disorders (GAD),explored by intracranial EEG (seteroelectroencephalography - SEEG) in Hospital

Treatment:

Behavioral: Anxiety-induced task

Behavioral: Neuropsychiatric assessment