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Clinical Trials/EUCTR2017-000755-97-Outside-EU/EEA
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.

Registry
who.int
Start Date
March 16, 2017
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Defitech Chair in Brain-Machine Interface, EPF

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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