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临床试验/NCT04102228
NCT04102228已完成不适用

A Randomized Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) and Multi-Modal Aphasia Treatment (M-MAT) for Post-Stroke Non-Fluent Aphasia

University of Calgary2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年4月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sean Dukelow

Associate Professor

University of Calgary

研究点 (2)

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