Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID05393518

Electroclinical Correlation of Anxiety Evidences From Intracerebral Recordings

Led by University Hospital, Bordeaux · Updated on 2025-07-25

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Bordeaux

Lead Sponsor

C

Centre National de la Recherche Scientifique, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

Anxiety disorders are the most common mental health conditions and can cause significant personal and financial challenges. Current treatments often do not fully relieve anxiety symptoms. This research focuses on understanding the brain mechanisms behind pathological anxiety, especially in patients with drug-resistant epilepsy who also have generalized anxiety disorder (GAD). The study compares patients with drug-resistant epilepsy with and without GAD to explore these mechanisms. The study uses intracerebral electroencephalographic recordings (stereoelectroencephalography or sEEG) performed during a pre-surgical assessment for epilepsy. Participants will complete a specially designed task exposing them to anxiety-provoking scenarios based on their own anxious thoughts. These sessions will be monitored using sEEG, physiological stress measures, and anxiety level ratings to study brain activity and responses during anxiety exposure. Participants will undergo various assessments including neuropsychiatric evaluations and multiple anxiety and depression rating scales. Researchers will measure changes in brain activity within key brain networks involved in anxiety, and correlate these findings with clinical features and task performance. The study will monitor outcomes such as anxiety severity and cognitive function during the inclusion phase. The total study duration and follow-up details are aligned with the pre-surgical evaluation period.

CONDITIONS

Brief Title

Electroclinical Correlation of Anxiety

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Man or woman
  • Aged 18 to 65
  • Diagnosed with drug-resistant epilepsy
  • Undergoing phase II pre-surgical assessment with intracerebral electrophysiological exploration by stereo-EEG
  • Either meeting or not meeting DSM-5 criteria for generalized anxiety disorder
  • Full scale IQ above 75 on WAIS IV or above 81 on IAG
  • Affiliate or beneficiary of a social security scheme
  • Able to give free, informed written consent
Not Eligible

You will not qualify if you...

  • Unable to give personal consent
  • Under legal protection measures such as curatorship or guardianship
  • Diagnosed with chronic delusional disorders like schizophrenia
  • Moderate or high suicide risk based on psychiatric interview or MADRS score
  • Pregnant or breastfeeding
  • Having severe or decompensated somatic illness other than drug-resistant epilepsy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Inpatient Treatment

Duration - Duration of the intracerebral EEG monitoring during pre-surgical assessment

Participants with drug-resistant epilepsy undergo intracerebral electrophysiological exploration by stereo-EEG in hospital. During this period, participants will perform a custom behavioral task exposing them to anxiety scenarios while brain activity and stress parameters are monitored.

Continuous monitoring during hospital stay

Trial Site Locations

Total: 1 location

1

CHU de Bordeaux

Bordeaux, France, 33076

Actively Recruiting

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Research Team

J

Jérôme Aupy, Dr

T

Thomas Bienvenu, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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