A Randomized Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) and Multi-Modal Aphasia Treatment (M-MAT) for Post-Stroke Non-Fluent Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient within one week of intervention completion
研究概览
简要总结
Many stroke survivors experience aphasia, a loss or impairment of language affecting the production or understanding of speech. One common type of aphasia is known as non-fluent aphasia. Patients with non-fluent aphasia have difficulty formulating grammatical sentences, often producing short word fragments despite having a good understanding of what others are trying to communicate to them. Speech language pathologists (SLPs) play a central role rehabilitating persons with aphasia and administer therapy in an attempt to improve communication skills. Despite standard therapy, approximately 50% of individuals who experience aphasia acutely continue to have language deficits more than 6 months post-stroke.
In most people, Broca's area is dominant in the left side of the brain. Following a left-sided stroke, the right-sided homologue of Broca's area (the pars triangularis), may adopt language function. Unfortunately, reorganizing language to the right side of the brain seems to be less effective than restoring function to the left hemisphere. Repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, can be used to suppress activity of specific regions in the right side of the brain to promote recovery of function in the perilesional area. Despite preliminary success in existing studies using rTMS in post-stroke aphasia, there is much work to be done to better understand the mechanisms underlying recovery. Responses to rTMS have been positive, yet heterogenous, which may be related to timing of treatments following stroke.
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
- •Isolated left middle cerebral artery (MCA) stroke within past 6 months (sub-acute) or more than 6 months ago (chronic)
- •Stroke type: Ischemic or hemorrhagic
- •Non-fluent aphasia as determined by the Western Aphasia Battery (Fluency < 5)
- •English is first or primary language
- •Ability to follow 3-step commands
排除标准
- •Prior stroke to the right frontal lobe
- •Current diagnosis of moderate to severe depression
- •Diagnosis of any other psychiatric condition
- •History of other neurologic disorders (e.g., epilepsy, brain tumor)
- •Contraindication to MRI or TMS (metal in the head or any implanted electrical device)
- •Has received intensive speech therapy within the past 6 months (>8 hours per week)
- •Enrolled in another interventional study
结局指标
主要结局
Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient within one week of intervention completion
时间窗: Baseline, within 1 week of completing the 10 day intervention
Western Aphasia Battery Aphasia quotient (WAB-AQ) composite score, composed of fluency, spontaneous speech, naming, and comprehension sub-tests. Scores range from 0 to 100, with higher scores indicating better overall speech and language abilities. Positive change from baseline indicates better outcome.
Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient at 3 months
时间窗: Baseline and 3-month follow-up
Western Aphasia Battery Aphasia quotient (WAB-AQ) composite score, composed of fluency, spontaneous speech, naming, and comprehension sub-tests. Scores range from 0 to 100, with higher scores indicating better overall speech and language abilities. Positive change from baseline indicates better outcome.
次要结局
- Scenario Test (UK)(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Connected speech sample(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Cognitive Linguistic Quick Test - aphasia administration(Baseline)
- Resting-state Functional Magnetic Resonance Imaging(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Stroke Aphasic Depression Questionnaire (SADQ)(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Stroke and Aphasia Quality of Life Scale (SAQOL)(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Western Aphasia Battery - Bedside (WAB)(Screening appointment)
- Trained and Untrained Picture Naming(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Overt Naming Functional Magnetic Resonance Imaging(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Magnetic Resonance Spectroscopy(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Diffusion weighted Magnetic Resonance Imaging(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Communication Effectiveness Index(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
- Apraxia Battery for Adults (ABA)(Screening appointment)
研究者
Dr. Sean Dukelow
Associate Professor
University of Calgary
