跳至主要内容
临床试验/NCT04875936
NCT04875936招募中不适用

Rehabilitation of Reading Deficits in Subacute Stroke Using Functional Magnetic Resonance Imaging (fMRI) Neurofeedback and Motor Imagery

Kessler Foundation2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
28
试验地点
2
主要终点
Reading Aloud Accuracy

研究概览

简要总结

The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.

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
Single (Participant)

盲法说明

Participants will be masked to the nature of real-time fMRI neurofeedback they will receive: contingent or non-contingent.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First-ever left-hemisphere stroke < 3 months prior to study recruitment or healthy volunteer
  • Age: 18 - 80 years old
  • Fluent and literate in English prior to stroke
  • Reading deficits, defined as >3 errors on the Paragraphs test (subtests VIII, IX) of the Reading Comprehension Battery for Aphasia-2nd ed. (RCBA-2) in keeping with the healthy control accuracy criterion of 86-100% correct.

排除标准

  • Inability to consent or complete study tasks
  • Inability to undergo MRI (e.g., pregnancy, non-MRI compatible implants, claustrophobia)
  • A history of prior neurological disease (e.g., brain tumor, Alzheimer's disease)

研究组 & 干预措施

Motor Imagery and Contingent Neurofeedback (NFB)

Experimental

This group will receive real-time fMRI NFB on the bases of participant's own brain activity

干预措施: Motor Imagery and Real-Time fMRI Neurofeedback (Behavioral)

Motor Imagery and Non-contingent Neurofeedback (NFB)

Sham Comparator

This group will receive group will receive fMRI NFB based on another participant's brain activity

干预措施: Motor Imagery and Sham fMRI Neurofeedback (Behavioral)

结局指标

主要结局

Reading Aloud Accuracy

时间窗: change from baseline at intervention week 1, 2, and 3

Read aloud 136 words to produce an accuracy score in percent correct.

fMRI Brain Activity

时间窗: change from baseline at intervention week 1, 2, and 3

Whole-brain and region of interest activation and resting state functional connectivity

次要结局

  • Reading Comprehension Battery for Aphasia (RCBA-2)(change from baseline at 1 week follow up)
  • Western Aphasia Battery-Revised (WAB-R) Bedside(change from baseline at 1 week follow up)
  • Boston Naming Test (BNT-short)(change from baseline at 1 week follow up)
  • Palm Trees and Pyramids test(change from baseline at 1 week follow up)
  • Geriatric Depression Scale (GDS)(change from baseline at 1 week follow up)
  • Neuro evaluation(baseline and 1 week follow up)

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Boukrina

Research Scientist

Kessler Foundation

研究点 (2)

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