Electroclinical Correlation of Anxiety, Evidences From Intracerebral Recordings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in neuronal coherence in the frontolimbic network
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in neuronal coherence in the frontolimbic network
时间窗: 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.
次要结局
- Generalized Anxiety Disorders (GAD) severity score at The Penn State Worry Questionnaire (PSWQ)(Inclusion (Day 1))
- Beck Anxiety Inventory (BAI)(Inclusion (Day 1))
- SEEG power spectrum changes(Inclusion (Day 1))
- Auditory and visual memory index (MEM IV)(Inclusion (Day 1))
- Wechsler adult intelligent scale Score (WAIS-R full scale IQ)(Inclusion (Day 1))
- Analog Visual Scale (EVA) Anxiety score(Inclusion (Day 1))
- Neurological Disorders Depression Inventoiry for Epilepsy (NDDI-E)(Inclusion (Day 1))
- Beck Depression Inventory (BDI)(Inclusion (Day 1))
- Hamilton Antiety rating Scale (HAM-A) Score(Inclusion (Day 1))
- Quality of life scale applied to epilepsy (QOLI-E 31)(Inclusion (Day 1))
- Generalized Anxiety Disorder 7- items (GAD-7)(Inclusion (Day 1))
- Montgomery and Asberg Depression Rating Scale (MADRS) Score(Inclusion (Day 1))
- State Anxiety Inventory (STAI)(Inclusion (Day 1))