Electroclinical Correlation of Anxiety
IRAnxNet
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2022
CompletedFirst Posted
Study publicly available on registry
May 26, 2022
CompletedStudy Start
First participant enrolled
October 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 11, 2026
July 25, 2025
July 1, 2025
4 years
March 29, 2022
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Inclusion (Day 1)
Secondary Outcomes (13)
Generalized Anxiety Disorders (GAD) severity score at The Penn State Worry Questionnaire (PSWQ)
Inclusion (Day 1)
SEEG power spectrum changes
Inclusion (Day 1)
Wechsler adult intelligent scale Score (WAIS-R full scale IQ)
Inclusion (Day 1)
Auditory and visual memory index (MEM IV)
Inclusion (Day 1)
Quality of life scale applied to epilepsy (QOLI-E 31)
Inclusion (Day 1)
- +8 more secondary outcomes
Study Arms (2)
Drug resistant epilepsy with GAD
EXPERIMENTALPatients suffering from drug-resistant epilepsy and generalized anxiety disorders (GAD),explored by intracranial EEG (seteroelectroencephalography - SEEG) in Hospital
Drug resistant epilepsy without GAD
ACTIVE COMPARATORPatients suffering from drug-resistant epilepsy without generalized anxiety disorders (GAD),explored by intracranial EEG (seteroelectroencephalography - SEEG) in Hospital
Interventions
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.
Screening for depression and anxiety
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Bordeaux
Bordeaux, 33076, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérôme Aupy, Dr
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2022
First Posted
May 26, 2022
Study Start
October 11, 2022
Primary Completion (Estimated)
October 11, 2026
Study Completion (Estimated)
October 11, 2026
Last Updated
July 25, 2025
Record last verified: 2025-07