Electroclinical Correlation of Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital, Bordeaux
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Anxiety-induced task
BehavioralSubjects 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 assessment
BehavioralScreening for depression and anxiety
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Drug resistant epilepsy with GADExperimental treatment 2 interventions
Group B: Drug resistant epilepsy without GADActive comparator 2 interventions
Trial outcomes
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.
Time frame
Inclusion (Day 1)Secondary outcomes
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
Time frame
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.
Time frame
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).
Time frame
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.
Time frame
Inclusion (Day 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Bordeaux
Lead sponsor
Centre National de la Recherche Scientifique, France
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov