Linking anxiety symptoms to deep brain activity
Electroclinical Correlation of Anxiety, Evidences From Intracerebral Recordings
This will try to see if brain recordings taken during presurgical monitoring in adults with drug‑resistant epilepsy reveal patterns tied to generalized anxiety disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05393518 on ClinicalTrials.gov |
What this trial studies
The protocol uses intracerebral stereoelectroencephalography (sEEG) recorded during phase II presurgical evaluation in patients with drug‑resistant epilepsy to capture deep brain electrical activity. Fifteen patients with comorbid generalized anxiety disorder and 15 epilepsy controls without GAD will complete a customized anxiety‑provoking behavioral task while sEEG, physiological stress markers, and self‑reported anxiety are recorded. Electrophysiological measures such as coherence and task‑related responses will be compared between groups and correlated with clinical characteristics. The approach aims to identify intracranial activity patterns linked to pathological anxiety that are not accessible with noninvasive imaging.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–65 with drug‑resistant epilepsy undergoing phase II sEEG presurgical monitoring who either meet DSM‑5 criteria for generalized anxiety disorder or serve as non‑anxious controls and meet the study IQ and consent requirements.
Not a fit: Patients not undergoing intracranial monitoring, those who do not meet the IQ or consent/legal criteria, people with major psychotic disorders or high suicide risk, or individuals without epilepsy are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the findings could point to specific brain activity signatures that guide more targeted treatments for anxiety in people with epilepsy.
How similar studies have performed: Functional imaging has repeatedly implicated deep brain regions in anxiety, but direct intracranial recording during provoked anxiety in humans is relatively novel and prior evidence from sEEG is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Jérôme Aupy, Dr — University Hospital, Bordeaux
- Study coordinator: Jérôme Aupy, Dr
- Email: jerome.aupy@chu-bordeaux.fr
- Phone: 05 56 79 56 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.