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临床试验/NCT03699930
NCT03699930已完成不适用

Impact of Neuromodulation on Language Impairments in Stroke Patients: a Multimodal Double-blind Randomized Controlled Study

Casa Colina Hospital and Centers for Healthcare2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年1月1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
24
试验地点
2
主要终点
Change in Western Aphasia Battery-Revised scores

研究概览

简要总结

Up to 40% of stroke survivors suffer from aphasia, making recovery of language abilities a top priority in stroke rehabilitation. Conventional speech and language therapy may have limited effectiveness. Leveraging multimodal data (behavioral, neuroimaging, and genetics), this study aims to 1) evaluate the efficacy of combining tDCS with speech therapy, 2) examine neural changes associated with recovery, 3) identify factors influencing response to treatment.

详细描述

Approximately one million people in the United States are living with aphasia, an acquired neurological disorder affecting the ability to use and/or understand language. This communication impairment affects up to 40% of stroke patients. Stroke victims usually prioritize speaking, writing, and walking as the three most important rehabilitation goals, two of these goals therefore involving communication. Conventional speech therapy strategies have nevertheless limited effectiveness in post-stroke aphasia. Indeed, approximately half of those affected will remain in this state despite intensive speech therapy. Effective novel treatment is therefore warranted to improve recovery in these patients. Recent evidence suggests that transcranial direct current stimulation (tDCS), a non-invasive, low-cost neuromodulation technique, applied in conjunction with speech therapy may be more effective in promoting language recovery than behavioral intervention alone.

A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke aphasics. Participants will be assigned to either the tDCS group or to the sham (placebo) group and will receive 20 minutes of concurrent speech and language therapy by a trained speech therapist over five consecutive days. Behavioral, EEG, and MRI data will be acquired within one week before and after intervention. Genetic samples will be collected once. Secondary behavioral outcome measures will be performed again 3 months following tDCS/sham intervention to assess long-term benefits.

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, Outcomes Assessor)

盲法说明

The only person knowing about this assignment will be the Principal Investigator.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between ages 18-85
  • At least 12 months post stroke
  • Diagnosed with aphasia due to ischemic or hemorrhagic stroke
  • English speaking
  • Right handed prior to stroke

排除标准

  • Nonverbal
  • Other neurological diseases/disorders
  • Not MRI-compatible (e.g. claustrophobia, metal implants in the head)

结局指标

主要结局

Change in Western Aphasia Battery-Revised scores

时间窗: At baseline and at week 3

WAB-R is an instrument for assessing the language function of adults with suspected neurological disorders as a result of a stroke.

次要结局

  • Change in Magnetic Resonance Imaging (MRI)(At baseline and at week 3)
  • Change in Test of Nonverbal Intelligence (TONI-4)(At baseline and at week 3)
  • Change in Communication Outcomes after Stroke (COAST)(At baseline, at week 3, and at week 17)
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS)(At baseline, at week 3, and at week 17)
  • Change in resting state Electroencephalograph (EEG) signals(At baseline and at week 3)
  • Change in Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)(At baseline, at week 3, and at week 17)

研究者

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

Amy Zheng

Research Scientist

Casa Colina Hospital and Centers for Healthcare

研究点 (2)

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