EUCTR2017-000755-97-Outside-EU/EEA
Active, not recruiting
Phase 1
Brain-computer interface and neuromuscular stimulation for rehabilitation following chronic stroke - BCI-NMES-CVA
Defitech Chair in Brain-Machine Interface, EPF0 sites32 target enrollmentMarch 16, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- I61 - Intracerebral haemorrhageI63 - Cerebral infarctionChronic condition (at least 10 months after occurrence of cerebrovascular accident)
- Sponsor
- Defitech Chair in Brain-Machine Interface, EPF
- Enrollment
- 32
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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