Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Boost in naming performance (percent correct) through levodopa as compared to placebo
研究概览
简要总结
The purpose of this study is to determine whether levodopa, in combination with a high frequency language training, is effective in boosting naming performance in patients with aphasia.
详细描述
Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether daily administration of levodopa, coupled with several hours of language training every day, will significantly improve naming abilities in patients with aphasia as compared to placebo administration. We furthermore examine with magnetic resonance imaging which brain regions need to be functionally intact for a dopaminergic improvement of language therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •for patients with aphasia:
- •Unilateral cerebrovascular accident (stroke) in the territory of the arteria media
- •Time post onset: > 6 months
- •Aphasia with anomia
- •Age between 18-75 years
- •Premorbid right-handedness
- •Primary language: German
排除标准
- •for patients and healthy controls:
- •Known allergy to levodopa or tartrazine
- •History of medication/drug abuse
- •Acute nicotine withdrawal or > 15 cigarettes per day
- •> 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
- •> 50 grams of alcohol per day
- •Severe hypertonia (systole >180 mm Hg)
- •Severe arteriosclerosis
- •Diabetes, asthma, or glaucoma
- •Severe hearing disability
- •Evidence for severe hippocampal damage
- •Premorbid depression or psychosis
- •Medication with dopamine agonists or antagonists
- •Parkinsonian symptoms
- •Changes in anticonvulsive medication during the week prior to study enrollment
结局指标
主要结局
Boost in naming performance (percent correct) through levodopa as compared to placebo
时间窗: immediately after each treatmentphase
Brain activity pattern in successfully trained patients
时间窗: immediately after each treatmentphase
次要结局
- Stability of naming performance after one month and six months post treatment(from 1 month untill 6 months after treatment completion)