Brain-computer interface and neuromuscular stimulation for rehabilitation following chronic stroke - BCI-NMES-CVA

Defitech Chair in Brain-Machine Interface, EPF0 个研究点目标入组 32 人开始时间: 2017年3月16日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•1) Age more than 18 years-old
•2) Victim of cerebrovascular accident (stroke)
•3) Patients in their chronic phase, more than 10 months after stroke.
•4) Severe paralysis of the arm
•5) Ability to understand information and ability to give a free and informed consent
•6) Good eyesight and hearing, or corrected
•7) First stroke (infarction), preferably ischemic stroke
•8) Unilateral cortical lesion (left or right hemisphere) or subcortical lesion, lesions of the supra-pontic corticospinal pathway causing a motor deficit of upper limb
•9) Paresis / central paralysis of the upper limb (the intervention focuses on upper limb; The presence of other motor deficits is not a criterion of exclusion)
•10) Ability to understand instructions to perform mental tasks, like mental imagery or attempt of motor activity (more specifically, the ability to imagine/attempt movements of the upper limbs). These capacities are estimated with neurophysiological assessments
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•1) Anything that hampers the proper EEG acquisition (for example, a skin contamination, scalp wound, dermatitis, uncontrolled/coarse muscle activity or an electrically noisy environment)
•2) Heavy medication affecting the central nervous system (including vigilance)
•3) Concomitant serious illnesses (comorbidity: fever, infection, metabolic, cardiac arrest)
•4) Multiple infarctions
•5) Complete unlilateral spatial neglect
•6) Inability to perform mental and motor imagery tasks
•7) Severe inability to understand and communicate (eg, severe aphasia), inability to understand the information given, the objectives of the study or instructions to perform tasks.
•8) Inability to concentrate for 2 hours.
•9) Severe dystonia / involuntary movements
•10) Other concurrent neurological disorders (eg, Parkinson's disease)
•11) High level of spasticity and / or pain
•12) Pacemakers, other active implants such as pumps, pacemakers for pain or phrenic pacing
•13) Severe or recent heart disease
•14) Implants in the area of the flow of current under the FES electrodes

发起方

Defitech Chair in Brain-Machine Interface, EPF