NCT00640198已完成4 期
A 24-Week Pilot, Double-Blind, Randomized, Parallel, Placebo-Controlled Study of Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:Correlation With Cognitive Evoked Potentials During Recovery.
Gabinete Berthier y Martínez1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2005年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Language function (overall aphasia severity).
研究概览
简要总结
- Aphasia, the loss or impairment of language caused by brain damage, is one of the most devastating cognitive impairments of stroke. Aphasia can be treated with combination of speech-language therapy and drugs. Conventional speech-language therapy in chronic aphasic subjects is of little help and several drugs have been studied with limited success. Therefore other therapeutic strategies are warranted.
- Recent data suggest that drugs (memantine) acting on the brain chemical glutamate may help the recovery of cognitive deficits, included language, in subjects with vascular dementia. The present study examines the safety profile and efficacy of memantine paired with intensive language therapy in subjects with stroke-related chronic aphasia (more than 1 yr. of evolution).
详细描述
- The efficacy of drugs that act on glutamate such as the N-methyl-D-aspartic acid (NMDA) receptor antagonist memantine requires to be explored in this population. The rationale for using memantine in post-stroke aphasia comes from recent studies on vascular dementia. Data extracted from a recent Cochrane review of randomized controlled trials of memantine in different types of dementia (vascular dementia, Alzheimer's disease, mixed dementia) reveal, after 6 weeks of treatment, beneficial effects on cognition (including language), activities of daily living, behavior and global scales as well as in the global impression of change.
- Recovery from aphasia is possible even in severe cases. While speech-language therapy remains as the mainstay treatment of aphasia, its effectiveness has not been conclusively proved. This has motivated the planning of more rational therapies (e.g., constraint-induced language therapy [Pulvermüller et al., 2001; 32: 1621-1626]).
- In addition, the neural correlates of improvement of language function can now be readily detectable with event-related potentials. This is a noninvasive technique that can detect in real time functional brain changes during recovery promoted by the combined action of memantine and constraint-induced language therapy.
- The aim of the present study is to assess the efficacy, safety profile, and functional correlates of memantine paired with massed language therapy in a sample of patients with chronic poststroke aphasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic aphasia of more than one year duration
- •Must be able to complete protocol
排除标准
- •Major psychiatric illness
- •Severe global aphasia (precludes participation in constraint-induced language therapy)
研究组 & 干预措施
Group 1 Memantine
Active Comparator
Patients included in this group will receive memantine alone followed by memantine combined with intensive speech-language therapy.
干预措施: memantine (Drug)
Group 1 Memantine
Active Comparator
Patients included in this group will receive memantine alone followed by memantine combined with intensive speech-language therapy.
干预措施: constraint-induced language therapy (CIAT) (Behavioral)
Group 2
Placebo Comparator
Patients included in this group will receive placebo alone followed by memantine combined with intensive speech-language therapy.
干预措施: constraint-induced language therapy (CIAT) (Behavioral)
Group 2
Placebo Comparator
Patients included in this group will receive placebo alone followed by memantine combined with intensive speech-language therapy.
干预措施: placebo (Drug)
结局指标
主要结局
Language function (overall aphasia severity).
时间窗: 24 weeks
次要结局
- Depression(24 weeks)
- Cognitive evaluation of language function(24 weeks)
- Changes in event-related potential(24 weeks)
研究者
研究点 (1)
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