Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change from the baseline in the functional magnetic resonance imaging (fMRI)
研究概览
简要总结
With the main goal of generalising findings into Virtual Reality-Neurofeedback-Motor imagery (VR-NF-MI) system, this project aims to develop a new motor rehabilitation tool, for the upper limb, allied to the use of rising of information and communication technologies (ICT). By identifying correlations on the neural activity, during motor imagery and through brain imaging (fMRI), with distinct training protocols and feedback, these protocols are developed to create user-specific models that later can be used in NF-MI rehabilitation sessions.
详细描述
Every year millions of people worldwide suffer from stroke, being one of the leading causes of death and longterm disability. This leads to cognitive and motor impairments, resulting in loss of independence in their daily life together with an additional psychological impact in mood disorders and depression. Evolving to a chronic condition, stroke requires continuous rehabilitation and therapy. Personalised Virtual-Reality (VR) approaches have been shown to accelerate the recovery process compared to non-Information and communication technologies (ICT) based interventions. However, most of these novel VR approaches are suitable only for a reduced subset of patients, generally those with better recovery prognostics and better motor control. Thus, the idea of training the central nervous system was established, through EEG-based neurofeedback (NF) and motor-imagery (MI). Although the benefits of MI-NF have been illustrated in a plethora of studies, the reduced ability for stroke patients to use NF does not allow an accurate control, reducing the capabilities of MI-NF systems. The aim of this project is to develop a novel and more inclusive rehabilitation system with the use of novel ICT technologies, in order to overcome current limitations. This will be achieved by identifying the neural correlates of motor action during motor imagery through brain imaging (fMRI), and differences in brain activation with different training feedback protocols for formulating user-specific models that will be used later in NF-MI rehabilitation sessions. This will facilitate the use of neural interfaces to train the central nervous system; specifically, the investigators will develop a personalized EEG-based immersive NF through VR for MI training. The ultimate goal is to generalize the findings into a VR-NF-MI training paradigm for both admitted and ambulatory patients as well as continued domestic care.
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 (Outcomes Assessor)
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
- 否
入选标准
- •First stroke episode
- •More than six months after stroke
- •Stroke hemiplegia/hemiparesis, (Fugl Meyer below or equal to 47)
- •Capacity to understand and complete simple tasks
- •Know how to read and write
- •Motivation to participate
排除标准
- •Hemi spatial neglect
- •Depressive symptoms, moderate to severe
- •Presence of other neurological or orthopaedic problems
- •Severe eyesight problems
- •Claustrophobia
- •Presence of ferromagnetic materials
结局指标
主要结局
Change from the baseline in the functional magnetic resonance imaging (fMRI)
时间窗: Baseline, Final (4 weeks) and 1 month follow up
Analyze cortical activation, during motor imagery exercises, and cortical structure.
Change from the baseline in the Fugl Meyer Motor Assessment
时间窗: Baseline, Final (4 weeks) and 1 month follow up
Evaluates the motor function of the affected upper limb. This section has a maximum score of 66 and changes to a higher score means an evolution on motor recovery.
次要结局
- Change from the baseline in the Geriatric Depression Scale (GDS)(Baseline, Final (4 weeks) and 1 month follow up)
- Change from the baseline in the Kinesthetic and Visual Imagery Questionnaire (KVIQ)(Baseline, Final (4 weeks) and 1 month follow up)
- Change from the baseline in the Montreal Cognitive Assessment (MoCA)(Baseline, Final (4 weeks) and 1 month follow up)
- Change from the baseline in the Modified Ashworth Scale (MAS)(Baseline, Final (4 weeks) and 1 month follow up)
- Change from the baseline in the electroencephalography (EEG) data(In all 12 sessions for 4 weeks)
研究者
Sergi Bermúdez i Badia
Associate Professor
Universidade da Madeira
