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.
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
- Conditions the study is for
- Anxiety Disorder, Generalized Anxiety Disorder, Drug Resistant Epilepsy
- What is being tested?
- Anxiety-induced task and Neuropsychiatric assessment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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
- 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
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 group | Role | What they receive |
|---|---|---|
| Drug resistant epilepsy with GAD | Experimental | Patients 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 GAD | Active comparator | Patients 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted26 May 2022
- Study start11 Oct 2022
- Primary completion11 Oct 2026 (estimated)
- Study completion11 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Jérôme Aupy, Dr, Principal investigator, University Hospital, Bordeaux
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroclinical Correlation of Anxiety, Evidences From Intracerebral Recordings
- ClinicalTrials.gov ID
- NCT05393518
- Acronym / sponsor ID
- IRAnxNet / CHUBX 2020/63
- Keywords
- Focal epilepsy, Generalized Anxiety Disorder, Intracranial recordings, Stereoenectroencephalography, Coherence, Networks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 11 Oct 2026 (estimated)
- Study completion
- 11 Oct 2026 (estimated)
- First posted
- 26 May 2022 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug resistant epilepsy with GAD | Experimental | Behavioral: Anxiety-induced task, Behavioral: Neuropsychiatric assessmentPatients suffering from drug-resistant epilepsy and generalized anxiety disorders (GAD),explored by intracranial EEG (seteroelectroencephalography - SEEG) in Hospital |
| Drug resistant epilepsy without GAD | Active comparator | Behavioral: Anxiety-induced task, Behavioral: Neuropsychiatric assessmentPatients suffering from drug-resistant epilepsy without generalized anxiety disorders (GAD),explored by intracranial EEG (seteroelectroencephalography - SEEG) in Hospital |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Anxiety-induced taskSubjects 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. | Behavioural | Drug resistant epilepsy with GAD, Drug resistant epilepsy without GAD |
| Neuropsychiatric assessmentScreening for depression and anxiety | Behavioural | Drug resistant epilepsy with GAD, Drug resistant epilepsy without GAD |
Primary outcome
Change in neuronal coherence in the frontolimbic network
Time frame: Inclusion (Day 1)
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.
13 secondary outcomes
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)
Analog Visual Scale (EVA) Anxiety score
Time frame: Inclusion (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jérôme Aupy, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
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.