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Recruiting NCT05393518

Electroclinical Correlation of Anxiety

No phase Interventional Anxiety Disorder Generalized Anxiety Disorder Drug Resistant Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anxiety-induced task, Neuropsychiatric assessment.
Who it may be relevant to
Registry conditions: Anxiety Disorder, Generalized Anxiety Disorder, Drug Resistant Epilepsy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Electroclinical Correlation of Anxiety, Evidences From Intracerebral Recordings

Overview

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 15 patients suffering from drug-resistant epilepsy and generalized anxiety disorders (GAD), explored by intracranial sEEG, and 15 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.

Interventions

  • Behavioral Anxiety-induced task
    Subjects will be asked to describe their most anxious thoughts and write each of them in a detailed scenario. The scenarios will be based on the answers to the Worry and Anxiety Questionnaire, in order to validate the procedure by a standardized examination. During the task, the scenarios will be successively presented to the subjects, on a digital computer medium in written and oral format. Subjects will be asked to actively focus on these negative thoughts with maximum concern, without seeking
  • Behavioral Neuropsychiatric assessment
    Screening for depression and anxiety

Primary outcome measures

  • Change in neuronal coherence in the frontolimbic network [Time frame: Inclusion (Day 1)]
Secondary outcome measures (12)
  • Generalized Anxiety Disorders (GAD) severity score at The Penn State Worry Questionnaire (PSWQ) [Time frame: Inclusion (Day 1)]
  • SEEG power spectrum changes [Time frame: Inclusion (Day 1)]
  • Wechsler adult intelligent scale Score (WAIS-R full scale IQ) [Time frame: Inclusion (Day 1)]
  • Auditory and visual memory index (MEM IV) [Time frame: Inclusion (Day 1)]
  • Quality of life scale applied to epilepsy (QOLI-E 31) [Time frame: Inclusion (Day 1)]
  • Neurological Disorders Depression Inventoiry for Epilepsy (NDDI-E) [Time frame: Inclusion (Day 1)]
  • Generalized Anxiety Disorder 7- items (GAD-7) [Time frame: Inclusion (Day 1)]
  • Beck Depression Inventory (BDI) [Time frame: Inclusion (Day 1)]
  • Montgomery and Asberg Depression Rating Scale (MADRS) Score [Time frame: Inclusion (Day 1)]
  • State Anxiety Inventory (STAI) [Time frame: Inclusion (Day 1)]
  • Beck Anxiety Inventory (BAI) [Time frame: Inclusion (Day 1)]
  • Hamilton Antiety rating Scale (HAM-A) Score [Time frame: Inclusion (Day 1)]

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 or IAG > 81
  • 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 moderate or 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) or a score > 2 on item 10 of the MADRS, assessing suicidal risk;
  • Being pregnant or breastfeeding
  • Have severe and / or decompensated somatic illness other than drug-resistant epilepsy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • CHU de Bordeaux — Bordeaux

Identifiers

NCT: NCT05393518 · CHUBX 2020/63

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗