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Anxiety DisorderIRAnxNetNCT05393518

Electroclinical Correlation of Anxiety

A study testing Anxiety-induced task and Neuropsychiatric assessment in people with Anxiety Disorder and Generalized Anxiety Disorder, run by University Hospital, Bordeaux at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Anxiety-induced task and Neuropsychiatric assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
11 Oct 2022to 11 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • CHU de Bordeaux

    Bordeaux, 33076

    Jérôme AUPY, Dr, 05 56 79 56 79, jerome.aupy@chu-bordeaux.fr

    Thomas BIENVENU, 05 56 56 17 98, thomas.bienvenu@u-bordeaux.fr

    Recruiting

Other trials in France

About this study

Official title: Electroclinical Correlation of Anxiety, Evidences From Intracerebral Recordings

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.

Read the 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.

Being tested
Anxiety-induced task, Neuropsychiatric assessment
Keywords
Focal epilepsy, Generalized Anxiety Disorder, Intracranial recordings, Stereoenectroencephalography, Coherence, Networks
Medical subject headings
Anxiety Disorders, Generalized Anxiety Disorder, Drug Resistant Epilepsy, Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anxiety-induced taskBehavioural

    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 to control their emotions.

  • Neuropsychiatric assessmentBehavioural

    Screening for depression and anxiety

Study groups in NCT05393518
Study groupRoleWhat they receive
Drug resistant epilepsy with GADExperimentalPatients suffering from drug-resistant epilepsy and generalized anxiety disorders (GAD),explored by intracranial EEG (seteroelectroencephalography - SEEG) in Hospital
Receives: Behavioral: Anxiety-induced task; Behavioral: Neuropsychiatric assessment
Drug resistant epilepsy without GADActive comparatorPatients suffering from drug-resistant epilepsy without generalized anxiety disorders (GAD),explored by intracranial EEG (seteroelectroencephalography - SEEG) in Hospital
Receives: Behavioral: Anxiety-induced task; Behavioral: Neuropsychiatric assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in neuronal coherence in the frontolimbic network

    Change in neuronal coherence in the frontolimbic network between the basal condition and the expression of acute anxiety induced induced by exposure to an anxiety-inducing scenario between patients suffering from GAD and controls. Local brain activities tend to organize in oscillatory patterns. In order to determine if neurnal activities in frontal and limbic areas at similar oscillatory frequencies synchronize as a substrate or marker for anxiety, we will perform a coherence analysis. The coherence study estimates the consistency of the relative amplitude and phase of two signals in a given frequency spectrum, and will take its values in the interval [0.1]. The variation of coherence value will be compared between relevant epochs (anxiety-induced scenario and baseline) and between patients suffering from GAD and controls.

    Measured: Inclusion (Day 1)

Secondary outcomes (13)
  1. Generalized Anxiety Disorders (GAD) severity score at The Penn State Worry Questionnaire (PSWQ)

    The Penn State Worry Questionnaire (PSWQ) is widely used in research and clinical practice to measure the tendency to worry in general. it includes 16 items assessing the general tendency to worry in adults. Patients are asked to respond spontaneously to 16 proposals by selecting the mention that best suits them

    Measured: Inclusion (Day 1)

  2. SEEG power spectrum changes

    the variation of power spectrum value or each frequency band (delta : [0.5 - 3] Hz, thêta : ]3 - 8] Hz, alpha : ]8 - 12] Hz, beta : ]12 - 25] Hz, gamma > 25 Hz) induced by exposure to an anxiety-inducing scenario will be compared between relevant epochs (anxiety-induced scenario and baseline) in patients suffering from GAD and controls, for each of the regions monitored.

    Measured: Inclusion (Day 1)

  3. Wechsler adult intelligent scale Score (WAIS-R full scale IQ)

    Test designed to measure the intellectual quotien (IQ) in terms of "verbal" and "performance". It is composed of 10 main mandatory subtests and 5 optional complementary subtests. These subtests are divided into four indices (verbal understanding, perceptual reasoning, working memory and processing speed). Scores ranged from 50 (minimum) to 150 (maximum).

    Measured: Inclusion (Day 1)

  4. Auditory and visual memory index (MEM IV)

    Normal values depend on its calibration according to the age of the subject and its level of education) is a test designed and validated to evaluate the learning and auditory and visual memory of a subject. They test different aspects of memory, including immediate recall, delayed recall, and recognition of visual and verbal stimuli.

    Measured: Inclusion (Day 1)

  5. Quality of life scale applied to epilepsy (QOLI-E 31)

    QOLI-E 31 containt 7 subtests evaluating the different health concepts (emotional well-being, social functioning, energy/fatigue, cognitive functioning, crisis anxiety, drug effects and overall quality of life).

    Measured: Inclusion (Day 1)

  6. Neurological Disorders Depression Inventoiry for Epilepsy (NDDI-E)

    Self-questionnaire of depressive disorder testing validated for epilepsy. Scores ranged from 0 (minimum) to 24(maximum). It consists of six items assessing depressive symptoms. Each item is rated on a 4-point Likert scale (1: never 2: rarely; 3: sometimes; 4: always or often, over the last two weeks). The total score is obtained by adding the score obtained for each item. A total score strictly higher than 15 must be suspected depressive syndrome. This questionnaire is also validated and has excellent psychometric properties (sensitivity and specificity) in the clinical population with epilepsy.

    Measured: Inclusion (Day 1)

  7. Generalized Anxiety Disorder 7- items (GAD-7)

    Self-test for anxiety disorders, including Generalized Anxiety Disorder. It consists of seven items assessing psychological and somatic anxiety symptoms. Each item is rated on a 4-point Likert scale (0: never; 1: several days; 2: more than half the time; 3: almost every day, over the last two weeks). The total score is obtained by adding the score obtained for each item (score ranging from 0 to 21). A total score strictly higher than 7 must make suspect a generalized anxiety disorder. If the score is higher than 7, it is advisable to have the diagnosis of TAG confirmed by a clinical psychiatric evaluation. This questionnaire is also validated and has excellent psychometric properties (sensitivity and specificity) in the clinical population with epilepsy.

    Measured: Inclusion (Day 1)

  8. Beck Depression Inventory (BDI)

    Scores ranged from 0 to 63. Self-assessment tool containing twenty-one elements that each describe one of the specific symptoms of depression. It can screen for recent depressive symptoms that have occurred in the past two weeks, and assess their severity. It can be used in subjects suffering from epilepsy. Each item is rated according to its intensity on a 4-point scale ranging from 0 (light intensity) to 3 (severe intensity). The maximum BDI score is 63 and the threshold for defining the presence of depression varies from 10 to 17, depending on the studies

    Measured: Inclusion (Day 1)

  9. Montgomery and Asberg Depression Rating Scale (MADRS) Score

    Hetero-questionnaire of mood assessment. It is rated by a trained clinician in its passing and consists of 10 items that each have a general definition and six degrees of severity of a symptom, with degrees 0, 2, 4 and 6 being themselves defined. The overall score (0 - 60) results from the addition of item scores.

    Measured: Inclusion (Day 1)

  10. State Anxiety Inventory (STAI)

    STAI is a two-part self-assessment questionnaire that independently assesses anxiety-trait and anxiety-state. They each include 20 items graduated in 4 degrees depending on their intensity or frequency. In the line-anxiety scale, the subject must indicate the point that best corresponds to the frequency of what he feels according to 4 degrees: 1 = almost never; 2 = sometimes; 3 = often; 4 = almost always. In the anxiety-state scale, the subject must indicate the point that best corresponds to the intensity of what he feels, also according to 4 degrees: 1 = no, 2 = rather no, 3 = rather yes, 4 = yes. The trait-anxiety scale is primarily used to assess the subject's usual anxiety temperament, while the state-anxiety scale is used to independently quantify current anxiety at the time of passing.

    Measured: Inclusion (Day 1)

  11. Beck Anxiety Inventory (BAI)

    utoquestionnaire that allows a quantitative estimate of the intensity of the anxiety feeling. It consists of 21 items of symptoms and attitudes resulting from panic and generalized anxiety disorders, evaluated over the last 7 days, graduated from 0 to 3 according to a Lickert scale

    Measured: Inclusion (Day 1)

  12. Hamilton Antiety rating Scale (HAM-A) Score

    Hetero-questionnaire intended to measure the severity of anxiety. It consists of 14 items corresponding to psychic and somatic anxiety symptoms noted on a 5-point Likert scale (0 - 4, in the increasing sense of severity). The overall score (0 - 56) results from the addition of the scores of items Hamilton et al. 1959. This is a classic trans-nosographic measure of the severity of anxiety. Its usefulness in this study consists of its evaluation by one. e clinician, while all other measures of anxiety are informed by patients

    Measured: Inclusion (Day 1)

  13. Analog Visual Scale (EVA) Anxiety score

    Anxiety self-assessessed during Anxiety task with Anxiety analog visual scale. (EVA-A)

    Measured: Inclusion (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study start11 Oct 2022
  3. Primary completion11 Oct 2026 (estimated)
  4. Study completion11 Oct 2026 (estimated)

Resources

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05393518
Sponsor's protocol ID
CHUBX 2020/63
Acronym
IRAnxNet
Status last verified
Jul 2025
First submitted
29 Mar 2022
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Anxiety-induced task and Neuropsychiatric assessment in people with Anxiety Disorder and Generalized Anxiety Disorder, run by University Hospital, Bordeaux 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jérôme Aupy, Dr (05 56 79 56 79, jerome.aupy@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in neuronal coherence in the frontolimbic network (time frame: Inclusion (Day 1)). 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 25 Jul 2025.

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