Targeted Transcranial Direct Current Stimulation to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Picture Naming of trained items
研究概览
简要总结
62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined semantic feature analysis/phonological components analysis treatment will be paired with the stimulation. Two assessment sessions will be pretreatment, 1 session immediately post-treatment, and 1 session at 3 months follow-up.
详细描述
Our long-term goal is to develop safe and effective treatments for the communication problems of Aphasia due to stroke that restore patients to higher levels of functioning, decrease disability, and promote higher quality of life. While language therapy for aphasia is effective, improvements are typically slow, and gains may be small. Noninvasive brain stimulation has been suggested as a method to enhance outcomes from language therapy. This study will examine whether outcomes for language therapy with brain stimulation are different from outcomes for language therapy without brain stimulation in people with aphasia. Our central hypotheses are (1) targeted right hemisphere HDtDCS (RH-HD-tDCS) administered in combination with language treatment will result in greater changes in naming accuracy than language treatment with the sham RH-HD-tDCS (2) RH-HD-tDCS plus language treatment will result in greater increases in communication within the affected hemisphere compared to language treatment plus sham RH-HD-tDCS (3) RH-HD-tDCS plus language treatment will result in greater increases in perilesional areas working together immediately post-treatment compared to language treatment plus sham RH-HD-tDCS
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must be greater than 6 months post-stroke
- •must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production
- •must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left hemisphere damage
- •must be stimulable for naming
排除标准
- •comorbid neurological disease.
- •damage to the anterior right hemisphere.
- •significant mood disorder.
- •substance/alcohol dependence or abuse within the past year
- •presence of any implanted electrical device or contraindications to tDCS or MRI
- •recent medical instability (within 4 weeks)
研究组 & 干预措施
Experimental: Active cathodal tDCS + Speech-language training
In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.
干预措施: Active Comparator: Experimental: Active cathodal tDCS + language training (Device)
Comparator: Placebo cathodal tDCS + Speech-language training
In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..
干预措施: Sham Comparator: Placebo cathodal tDCS + Speech and language (Behavioral)
结局指标
主要结局
Picture Naming of trained items
时间窗: 3 months
Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement
Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
时间窗: 3 months
Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, \& Railford, 2008)
Naming Efficiency of trained items
时间窗: 3 months
Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency
次要结局
- Discourse informativeness - Main Concept Production(3 months)
- Efficiency of discourse informativeness - Main Concept Production(3 months)
- Picture Naming of untrained items - Boston Naming Test(3 months)
- Naming Response Time of untrained items - Boston Naming Test(3 months)
- Naming Efficiency of untrained items - Boston Naming Test(3 months)
研究者
Jessica Richardson
Assistant Professor: SOM Neurosurgery
University of New Mexico