An interventional study of hand exoskeleton, brain-computer interface (BCI), and hand exoskeleton, sham BCI in Poststroke/CVA Paresis, sponsored by Russian Academy of Medical Sciences. Completed at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-09-29.
Sponsored by Russian Academy of Medical Sciences · Not applicable, Interventional, and Health services research
The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton technology based on EEG patterns recognition matching to motor imagery in post-stroke patients with hand paresis.
The BCI training is based on EEG activity patterns recording during hand motor imagery. A subject sit comfortably 1m from a computer screen which presents visual instructions during the session. The robotic exoskeleton is fixed to the paretic hand. Subject visually fixate on a circle presented in the center of the screen and receive instructions from three surrounding rhomboidal arrows. Subject is given three commands instructing them to relax or imagine slow hand opening movement with the right or left hand. The "Relax" command means that the subject have to sit still and look at the center of the screen. Commands are presented randomly, each of 10 sec duration.
A visual cue provides the subject with feedback regarding the mental task recognition: the central circle turned green if the classifier recognizes the task in agreement with the given command, or remains white if the signal is not recognized. In addition to visual feedback the subject is provided with kinesthetic feedback: the exoskeleton is opening the hand when the classifier recognizes the imagery of paretic hand movement.
The EEG is registered with 30 electrodes distributed over the head in accordance with the standard international 10-20 system. EEG signals are filtered from 5-30Hz. A Bayesian approach for EEG pattern classifying is used in the system. The activity sources most relevant for BCI functioning will be identified using an independent component analysis (ICA). Classification accuracy will by measured with Cohen's kappa (Kohavi and Provost, 1998). The procedure may consist from up to three sessions, the duration of 1 session is 10 min, there are 5 min time brake between session and total duration of procedure is up to 45 min. The number of procedures - at least 10. The maximal interval between procedures is 3 days.
Russian Academy of Medical Sciences is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
Device: hand exoskeleton, brain-computer interface (BCI),
Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
Device: hand exoskeleton, sham BCI
Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
Also known as: mind-machine interface
Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
Change from Baseline in hand paresis level and hand muscle spasticity
ARAT; Fugl-Meyer, Modified Ashworth scale
Time frame: Week 2
Long-term changes from Baseline in hand paresis level and hand muscle spasticity
ARAT; Fugl-Meyer, Modified Ashworth scale
Time frame: week 4, week 12, week 24
Plan to share: Undecided
The record gives a start of Jan 2015, a primary completion of Sep 2017 and a completion of Sep 2017. It does not say whether these dates are actual or estimated.
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Russian Academy of Medical Sciences