Can Enhancing Left Lateralization Using Transcranial Direct Current Stimulation Improve Recovery From Post-Stroke Aphasia?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Western Aphasia Battery - Revised: Naming and Word Finding Score
研究概览
简要总结
This study tests whether weak electrical stimulation of the brain is effective in improving language or reading difficulties occurring after a brain injury or stroke.
详细描述
This study tests whether aphasia or alexia, language and reading disorders occurring after traumatic brain injury or stroke, can be improved using transcranial direct current stimulation (tDCS). tDCS is a non-invasive technique that applies a small amount of direct electrical current to the brain in order to temporarily alter brain processing. Adults with aphasia/alexia resulting from stroke or traumatic brain injury will undergo baseline behavioral testing of various language and cognitive functions. Subjects who are willing to undergo MRI evaluation will also be scanned. They will then receive five days of either real or sham tDCS with standardized speech-language therapy, under a double-blind randomized placebo-controlled design. Behavioral assessments, and MRIs for those participating in the MRI portion of the study, will be performed again at multiple time points after completing tDCS to assess for changes in these measures.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Aphasia due to left hemisphere stroke diagnosed by a physician or speech-language pathologist
排除标准
- •Skull defect at or near the site of tDCS delivery
- •History of a significant stroke or traumatic brain injury other than the event that caused the aphasia
- •History of other brain conditions that could impact interpretation of results (such as multiple sclerosis, brain tumor, encephalitis, premorbid dementia)
- •Presence of implanted electrical or metallic devices in the head or body (except titanium; e.g. cochlear implants, implanted shunts with metal parts, deep brain stimulators, pacemakers, defibrillators)
- •Presence of ferrous metal in the head (e.g. shrapnel)
- •History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common selective serotonin reuptake inhibitor antidepressants)
- •Pregnancy
- •Severe comprehension deficits
- •Additional Exclusion Criteria for the optional MRI portion of the study:
- •Presence of metal in the body (except titanium)
- •Claustrophobia
结局指标
主要结局
Western Aphasia Battery - Revised: Naming and Word Finding Score
时间窗: Change from baseline to one day after treatment
This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.
次要结局
- Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient(Change from baseline to 1 day after treatment)
- Philadelphia Naming Test (PNT)(1 day after treatment)
- Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)(3 weeks post-treatment)
- Cognitive-Linguistic Quick Test (CLQT)(Change from baseline to 1 day after treatment)
- Reading Assessments(Change from baseline to 1 day after treatment)
- Motricity Index(Change from baseline to 1 day after treatment)