The Effect of Alcohol on Common Tremor Syndromes - A Prospective Double-blind Randomised Cross-over (Alcohol, Placebo) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change from baseline of the Total Tremor Power measured by accelerometry
研究概览
简要总结
The aim of this interventional study is to compare the response to alcohol in patients with essential tremor (ET), essential tremor plus (ETplus), dystonic tremor (DT), tremor associated with dystonia (TaD) and tremor in Parkinson´s disease (PD). The main question to be answered is:
• Is there a difference in the objective alcohol responsiveness of patients with ET, DT, TaD and PD?
Participants will receive either vodka with rum-flavoured orange juice with a target blood alcohol of 0.4 ‰ or a non-alcoholic rum-flavoured orange juice (vice versa on the second study day). Before and 30, 60 an 120 minutes after the study drink the participants will undergo a clinical examination of the tremor and accelerometry will be performed.
Researchers will compare alcohol and placebo in a randomized cross over way to see if the effect of alcohol on tremor exceeds the placebo effect.
详细描述
The researchers will include 45 patients (9 each) with essential tremor (ET), essential tremor plus (ETplus), dystonic tremor (DT), tremor associated with dystonia (DaT) or tremor in Parkinson´s disease (PD) from the Movement Disorders Outpatients Clinic of the Medical University of Graz.
Participants will be asked to stop any tremor influencing medication and alcohol intake 24 hours before testing. 4 hours before testing the participants should not eat or drink anything. The participants will be asked to bring an accompanying person and are not allowed to drive at the day of the study visit.
Each participant will be examined at two different days (intervention and placebo day) with at least one day in between. During the study participation the tremor influencing medication should not be changed. The study design is a randomized cross sectional design where each participant receives either alcohol or placebo and vice versa on the second study day. The participants will be asked to finish the study drink within 15 minutes.
Interventional day:
Participants will receive vodka with rum flavored orange juice with a target blood alcohol of 0.4 ‰ 30 minutes after alcohol consumption. The required amount of vodka will be calculated with the Widmark formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of PD, DT, TaD, ET or ETplus based on clinical diagnostic criteria
- •tremor in upper extremities
- •accompanying person for both study visits
排除标准
- •persons that are not willing to abstain from driving at both study days
- •patients with diseases prohibiting alcohol ingestion
- •patients with a history of alcohol abuse
- •pregnancy
研究组 & 干预措施
Interventional Day
Participants will receive vodka with rum flavored orange juice with a target blood alcohol of 0.4 ‰ 30 minutes after alcohol consumption. The required amount of vodka will be calculated with the Widmark formula.
干预措施: Alcoholic drink (Dietary Supplement)
Placebo Day
Participants will receive a non-alcoholic rum flavored orange juice.
干预措施: Placebo drink (Dietary Supplement)
结局指标
主要结局
Change from baseline of the Total Tremor Power measured by accelerometry
时间窗: 30 minutes after each study drink. Duration of measurement: 5 minutes.
The the total tremor power (TP) of the spectra between 1 and 30 Hz for each axis will be used. The square root of the sum of the squares of the TP of each accelerometer axis will be calculated. This will be the Change of the Total Tremor Power and will serve as a surrogate for tremor amplitude.
次要结局
- Change from baseline in TETRAS-P(30 minutes after each study drink. Duration of measurement: 3 minutes.)
- Change from baseline in UPDRS III(30 minutes after each study drink. Duration of measurement: 5 minutes.)
- Change from baseline in Visual Analogue Scale (VAS)(30 minutes after each study drink. Duration of measurement: 1 minute.)