Auricular Vagus Nerve Stimulation (auriStim) Against Alcohol-craving Measured by Pupillary Reaction - Pilotstudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- mean pupillary diameter
研究概览
简要总结
Background: The cause of the vegetative symptoms is a sympathetic driven misbalance of the autonomous nervous system. To restore vegetative balance in alcohol withdrawal syndrome new neuro-modulatory methods, such as percutaneous auricular vagal stimulation (pVNS) could be used. Measuring the pupil size is a suitable method to assess imbalances or dysfunctions of the vegetative regulation in individuals. Objective: The objective of this study is to assess the pupil reaction to the cholinergic antagonist tropicamide in alcohol withdrawal syndrome as a biomarker of the vegetative balance before and after pVNS. Methods: 30 patients aged between 20 and 65 were recruited in this open-label, controlled pilot trial with repeated measure design. pVNS was administered at the left cymba conchae for 72 hours with intermitted stimulation. Pupillometric recording lasted about 60 min and was performed at baseline and following pVNS. The reaction of the pupil to an anticholinergic agent was measured as a receptor-test in terms of a psychophysiological feedback mechanism to pVNS.
详细描述
The chronic consumption of alcohol leads to a pathophysiological adaptation of the nervous system, by an increase in glutamatergic receptors and a decrease in GABAergic receptor functions. Autonomic and psychomotor hyperactive disorders, such as nausea, tremor, diaphoresis, hypersensitive reflexes, hypertension, and tachycardia, as well as negative emotional states, characterized by restlessness, anxiety, dysphoria, and irritability occur 6 to 24 hours after cessation of alcohol consumption. The cause of the vegetative symptoms is a sympathetic driven misbalance of the autonomous nervous system. The negative state of health can last for a very long time and is the main reason for relapses.
Pharmacological treatment of alcohol withdrawal syndrome consists of ether Benzodiazepines or GHB is an endogenous metabolite of γ-aminobutyric acid (GABA).
The rate of successful treatment is lowest for alcohol dependence among all psychiatric disorders. Therefore, it seems important to carry out further interdisciplinary investigations in the direction of new and effective treatment methods. To restore vegetative balance in alcohol-withdrawal syndrome novel neuromodulatory approaches, such percutaneous auricular vagal stimulation (pVNS) could be beneficial.
The pupil size changes, like other physiological markers, e.g., hyperventilation, blood pressure and heart rate, serves as psychophysiological marker of the autonomic nervous system (ANS). Beside the fact that pupil size is determined by balance between the parasympathetic ANS (PANS) and the sympathetic ANS (SANS), measuring the static and dynamic pupillary diameters are suitable parameters measuring imbalances or dysfunction of the vegetative regulation. The pupil diameter oscillates spontaneously at low frequencies, which is an almost constant oscillatory change in the pupil size. Like pupil size, it is generally assumed that pupil oscillation is regulated by a dynamic interaction between parasympathetic (cholinergic) and sympathetic (noradrenergic) activity.
In this study, the investigator assessed the pupil reaction to the cholinergic antagonist tropicamide in alcohol withdrawal syndrome as a biomarker of the vegetative balance before and after pVNS. The Investigator hypothesized that pVNS will enhance the parasympathomimetic tone represented by a reduction of pupillary diameter in a parasympatholytic pharmacological challenge with tropicamide after vagal stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of alcohol dependence according to ICD-10 and DSM-V
- •aged between 20 and 65
- •Ability to perform oral and written informed consent to the study protocol
排除标准
- •age under 20 or over 65 years
- •taking medication affecting the pupillary measurements (opioids, acetylcholinesterase inhibitors, sympathomimetics)
- •positive pregnancy test
- •diagnosed anxiety disorders
- •multiple substance abuse disorder
- •ocular disease
- •delirious patients
- •biochemical implants
- •hemophilia
- •psoriasis vulgaris
结局指标
主要结局
mean pupillary diameter
时间窗: 3 days
change of the mean pupillary diameter in millimeter (mm), provoked by the parasympatholytic agent tropicamide (1 drop of 0.01% tropicamide solution administered into the left eye)
次要结局
- latency (milliseconds)(3 days)
- constrictive ratio (percent)(3 days)
- duration of constriction (milliseconds)(3 days)
- amplitude of constriction (millimeter)(3 days)
- Pupillary oscillations (Hz)(3 days)
- resting pupillary diameter (millimeter)(3 days)
研究者
Michael Treiber
Principal Investigator
Medical University of Vienna
