Closed Loop Motor Imagery Brain-Computer Interface using Sensorimotor Rhythms and Error-Related Potentials for Neurorehabilitation of Stroke Patients
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The Fugl Meyer scale for upper limb, Modified Rankin scale (MRC)
研究概览
简要总结
A structured summary should contain the following subheadings: Rationale/ gaps in existing knowledge, Novelty, Objectives, Methods, and Expected outcome.
Rationale: Stroke is a leading cause of disability globally. Passive movement and motor imagery (MI) induce similar EEG patterns over the motor cortex. Motor
imagery based Brain computer interface systems induces brain plasticity and the modulations in the sensory motor rhythm embedded in the EEG can be decoded
and translated for control of external devices. The identification and decoding of brain signal patterns associated with MI parameters such as speed and direction is
a challenging research problem .In BCI-based neurofeedback, the user’s imagination of hand movement decoded by the BCI is presented to the user as visual
feedback. The erroneous neurofeedback perceived by the human brain in the case of erroneous hand movement direction decoding triggers an endogenously
elicited brain response termed as Error-Related Potential (ErrP) and can be used to correct the error. Objectives: We aim to develop an online EEG-based MI-BCI for
stroke rehabilitation by decoding imagined hand movement kinematics and improve the accuracy of the MI decoding by integrating with ErrP detection. Novelty:
Integrating the online realtime multi class MI decoding module with the ErrP detection module to develop an online self-correcting BCI that actuates robotic hand
support towards the imagined direction/speed Methods The study design will be a feasibility randomised control study with 15 control subjects of stroke
undergoing conventional physiotherapy, 15 subjects of stroke undergoing MI” Intervention and another 15 subjects undergoing “MI with ErrP” Intervention. The
functional performance metrics will be documented pre and post BCI intervention and the efficacy assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Stroke patients with Motor paresis or plegia, assessed by Medical Research Council (MRC) grades
- •Both Hemorrhagic strokes and ischemic stroke (TOAST criteria) will be included 3.Cerebral venous thrombosis with focal deficits 4.First ever ischemic/hemorrhagic stroke 5.Patients will be recruited in both acute stages and chronic stages after the onset of stroke 6.CTIMRTshows evidence of stroke(infarct/hemorrhage) 7.Moderate to severe impairment of upper extremity function assessed by FMMA (Fugel-Meyer et al., 1975) score 10--50 8.Able to understand simple commands and imagine hand movements 9.Patients with adequate motivation and cognitive functioning to perform the experiments/games (MMSE score ranging from 15 to 30 preferably more than 24).
排除标准
- •l.Unconscious and Modified Rankin scale score 4 2.Those requiring ventilator support 3.Serious cardiovascular illness 4.Severe Respiratory Distress/ renal diseases 5.Patients with Psychiatric illness 6.Non cooperative participants 7.Stroke Mimics 8.Patients with Isolated CNS vasculitis/ systemic vasculitis, aneurysmal SAH 9.Transient ischemic events.
结局指标
主要结局
The Fugl Meyer scale for upper limb, Modified Rankin scale (MRC)
时间窗: At baseline and after every session weekly for 3 weeks of BCI intervention
次要结局
- (i) Classification accuracy, Subjectivity & Specificity, (ii) Spatial brain activation maps((iii) Resting-state functional network connectivity (an indicator of the overall)