Investigation of Frontopolar Transcranial Magnetic Stimulation on Neurobiological and Physiological Correlates of Craving in Alcohol Addiction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Changes in heart rate (beats per minute) during virutal reality (VR) alcohol cue exposure before and after TMS intervention
研究概览
简要总结
Alcohol dependence is a prevalent and debilitating condition characterized by a chronic inability to control alcohol consumption. Current treatment options offere limited efficacy, and there is a pressing need for innovative approaches. Continuous Theta Burst Stimulation (cTBS) is a form of transcranial magnetic stimulation (TMS) that has shown promise in modulating brain activity associated with craving and addiction. This study aims to explore the effects of cTBS over the left frontopolar cortex on neurobiological and physiological markers of craving in patients with alcohol dependence induced by virtual reality (VR) alcohol cue exposure. Additionally, this study aims to investigate the relationship between changes in physiological craving markers and baseline brain connectivity. The investigators hypothesize that cTBS TMS treatment will reduce physiological markers of craving in patients with alcohol dependence. Additionally, it is expected that baseline structural and functional connectivity will predict the degree of VR-induced heart rate increase after cTBS, providing insights into individual brain network variability in the effect of cTBS.
详细描述
Alcohol dependence is a prevalent and debilitating condition characterized by a chronic inability to control alcohol consumption despite adverse consequences. Current treatment options have limited efficacy, and there is a pressing need for innovative approaches. Continuous Theta Burst Stimulation (cTBS) is a form of transcranial magnetic stimulation (TMS) that has shown promise in modulating brain activity associated with craving and addiction. This study aims to explore the effects of cTBS over the left frontopolar cortex on neurophysiological markers of craving in patients with alcohol dependence and to investigate the relationship between these effects and baseline brain connectivity.
The objectives of this study are on the one hand to evaluate the impact of cTBS TMS administration over the left frontopolar cortex on neurophysiological craving markers (such as heart rate, skin conductance and skin temperature in a VR-based craving induction) in patients with alcohol dependence and on the other hand to investigate the relationship between baseline structural and functional brain connectivity (as assessed by magnetic resonance imaging; MRI) and the physiological response to craving induction after TMS.
This study aims to include 34 patients diagnosed with alcohol dependence. Inclusion criteria include adults aged 18-65 with an ICD-10 diagnosis of alcohol dependence. Exclusion criteria include severe neurological disorders or contraindications to TMS or MRI.
Participants will receive 15 sessions of cTBS TMS treatment over one week, targeting the left frontopolar cortex. Physiological parameters will be assessed before and after the TMS application using Virtual Reality Cue Exposure and Craving Assessment (VR-CECA). Structural and functional MRI scans will be conducted at baseline to assess brain connectivity.
The primary outcome measure will be the change in heart rate during VR-CECA craving induction. Secondary outcomes include changes in self-reported craving, skin conductance, and temperature during VR-CECA and the correlation between baseline brain connectivity and changes in heart rate increase during VR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •adults aged 18-65
- •ICD-10 diagnosis of alcohol dependence
- •Ability to give consent
- •Sinus rhythm in ECG
排除标准
- •Current psychotic symptoms in patients with psychotic disorders (F20, F23, F10.5)
- •Contraindication against TMS or MRI
- •Severe neurological disorders such as epilepsy, stroke, neuroinflammatory disorders (e.g., multiple sclerosis). A history of seizures only in the context of alcohol withdrawal does not represent a contraindication, unless the seizure happened in the last 3 weeks before study inclusion.
- •Acute withdrawal symptoms (CIWA-Ar > 5)
结局指标
主要结局
Changes in heart rate (beats per minute) during virutal reality (VR) alcohol cue exposure before and after TMS intervention
时间窗: Day 1 (pre-TMS, during VR alcohol cue exposure) and Day 5 (post-TMS, during VR alcohol cue exposure)
Changes in heart rate (BPM) during VR-based craving induction, measured before and after the TMS intervention. Heart rate is continuously recorded during VR alcohol cue exposure using a finger clip sensor. Mean, maximum, and minimum values are analyzed to assess physiological craving responses.
次要结局
- Changes in skin conductance (µS) during Virtual reality alcohol cue exposure(Day 1 (pre-TMS, during VR alcohol cue exposure) and Day 5 (post-TMS, during VR alcohol cue exposure))
- Changes in skin temperature (°C) during Virtual reality alcohol cue exposure(Day 1 (pre-TMS, during VR alcohol cue exposure) and Day 5 (post-TMS, during VR alcohol cue exposure))
- Changes in in self-reported craving during VR exposure using Visual Analogue Scale(Day 1 (pre-TMS; pre-VR and post-VR) and Day 5 (post-TMS; pre-VR and post-VR))
- Changes in self-reported craving following TMS intervention assessed with Mannheimer Craving Scale (MaCS)(At baseline (Pre-TMS) and on day 5 (post-TMS))
- Changes in self-reported craving following TMS intervention assessed with Penn Alcohol Craving Scale (PACS)(At baseline (Pre-TMS) and on day 5 (post-TMS))
- Changes in self-reported craving following TMS intervention assessed via Craving-Automatized-Scale-Alcohol (CAS-A)(At baseline (Pre-TMS) and on day 5 (post-TMS))
- Correlation between baseline brain connectivity and changes in heart rate (BPM) increase during VR(MRI and therefore structural and functional connectivity is assessed at baseline (day 0) and heart rate change during VR sessions before TMS intervention on day 1 and after the TMS intervention on day 5)
研究者
Jonathan Repple
Prof. Dr.
Goethe University