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临床试验/NCT04188132
NCT04188132Unknown不适用

EEG Based Brain Computer Interface in Chronic Stroke Survivors for Upper Limb Rehabilitation- A Pilot Study Using Motor Execution and Motor Imagery

University of Houston2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年11月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Fugl-Meyer Assessment score (Upper limb)(Min0-Max66;Total 66)

研究概览

简要总结

Biomedical and Engineering approaches form a key element to neurological rehabilitation of upper limbs. Brain Computer Interface (BCI) using Motor execution and Motor Imagery are known to aid motor recovery in stroke. The purpose of this study is to demonstrate that Noninvasive Sensorimotor Rhythm (SMR) based EEG based BCI using motor execution and Motor Imagery tasks can aid in rehabilitation of upper limb movements in chronic stroke.

The project aims to explore an SMR-based BCI system that can exploit the sensorimotor rhythm voluntary modulation to play a virtual game as neurofeedback using motor executory tasks and imagined hand movements by stroke patients, who suffer from upper limb disability.

详细描述

Brain Computer Interface (BCI) using Motor execution and Motor Imagery are known to aid motor recovery in stroke. The purpose of this study is to demonstrate that Noninvasive Sensorimotor Rhythm (SMR) based EEG based BCI using motor execution and Motor Imagery tasks can aid in rehabilitation of upper limb movements in chronic stroke.

The project aims to explore an SMR-based BCI system that can exploit the sensorimotor rhythm voluntary modulation to play a virtual game as neurofeedback using motor executory tasks and imagined hand movements by stroke patients, who suffer from upper limb disability. Studies have shown that movement and motor imagery (MI) (i.e., the mental rehearsal of a movement without any activation of the muscles) induce similar EEG patterns over the motor cortex.

Movement execution, preparation and even observation are usually accompanied by a decrease in µ- and β-rhythm in the cortical area representing the involved body segment. Such a reduction is called event-related desynchronization (ERD).The increase in µ-rhythm, i.e. event-related synchronization (ERS), is observed in the regions of the brain representing body segments, which are not involved in the task.This study is a pilot study to examine the feasibility of a SMR based EEG BCI using motor task and motor imagery and involve a gaming feedback for same.

The first two days will be used for calibrating the BMI using commands in computer screen followed by further two days for testing the BMI and feedback control during gaming in computer to move the ball in the computer screen.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • age: 21-75 years
  • Subacute or chronic stroke; interval of at least 3 months and interval of at least 6 months from stroke to time of enrollment, respectively.
  • no cerebellar signs or bilateral motor deficit
  • Cognitive ability to consent, assimilate, and participate actively in the treatment protocol (Mini Mental State Examination score > 24 points, out of a total 30 indicating normal cognitive ability);
  • Modified Rankin scale scores 1-3 (Mild-Moderate functional disability post-stroke);
  • Modified Ashworth Scale of Spasticity score <= 3 (ranges from 0-4 with 4 reflecting maximum spasticity)
  • No epilepsy /usage of antiepileptic drug
  • ◦ Subjects with Stroke will be included if they have:
  • unilateral impaired upper limb
  • Able to initiate hand movements like opening and closing fist and no joint contracture or severe spasticity in the affected upper limbs.
  • Sufficient sitting balance to participate in experimental activities.
  • No condition (e.g. severe arthritis, central pain) that would interfere with the administration of motor function tests.
  • English-language comprehension and cognitive ability sufficient to give informed consent (MMSE >=24) and to cooperate with the intervention.

排除标准

  • • Orthopedic conditions of either upper or lower extremity that would affect performance on the study
  • untreated depression that may affect motivation to participate in the study
  • vascular cognitive impairment interfering with comprehending the tasks
  • Individuals with stroke who have been diagnosed with cognitive or severe visual deficits, hemineglect, uncontrolled angina, or pregnancy
  • no psychiatric or neurological condition other than stroke
  • ◦ Stroke will be excluded if they have:
  • Pregnancy (Self -reported)
  • Dementia (MMSE score less than 24)
  • Recurrence of stroke (Occurrence of new focal deficits reported by patient or detected by PI on examination during visits)

结局指标

主要结局

Fugl-Meyer Assessment score (Upper limb)(Min0-Max66;Total 66)

时间窗: 4 days

Change in Hand strength

Decoding motor intent of hand movements using Scalp Electroencephalography(EEG)

时间窗: 4 days

Electroencephalographic spectral power changes during Motor execution and Motor Imagery of hand movements in stroke subjects

次要结局

未报告次要终点

研究者

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

Subasree Ramakrishnan

Visiting Professor

University of Houston

研究点 (2)

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