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Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients (iMove)

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ClinicalTrials.gov Identifier: NCT02325947
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
Pirogov Russian National Research Medical University
Information provided by (Responsible Party):
Roman Lyukmanov, Russian Academy of Medical Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Poststroke/CVA Paresis Device: hand exoskeleton, brain-computer interface (BCI), Device: hand exoskeleton, sham BCI Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Multicentre Randomized Single Blind Placebo Controlled Study to Assess Efficacy of Hand Exoskeleton Controlled by Motor Imagery Based BCI for Post Stroke Patients Movement Rehabilitation
Study Start Date : January 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
 Device: hand exoskeleton, brain-computer interface (BCI),
Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
Other Name: mind-machine interface
Sham Comparator: Placebo group
Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
 Device: hand exoskeleton, sham BCI
Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in hand paresis level and hand muscle spasticity [ Time Frame: Week 2 ]
    ARAT; Fugl-Meyer, Modified Ashworth scale


Secondary Outcome Measures :
  1. Long-term changes from Baseline in hand paresis level and hand muscle spasticity [ Time Frame: week 4, week 12, week 24 ]
    ARAT; Fugl-Meyer, Modified Ashworth scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Medical history of primary acute cerebrovascular event (ischemic or hemorrhagic stroke) at least 4 weeks before screening
  • focal stroke located in a hemisphere
  • post stroke hand paresis (mild to plegia according to Medical Research Council (MRC) Scale for Muscle Strength)

Exclusion Criteria:

  • Montreal Cognitive Assessment (MoCA) scale < 22
  • Left handedness
  • Sensory aphasia
  • Severe impairment of vision
  • Modified Ashworth Scale (MAS) ≥ 4
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325947


Locations
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Russian Federation
Research Center of Neurology of RAMS
Moscow, Russian Federation, 125367
Sponsors and Collaborators
Russian Academy of Medical Sciences
Pirogov Russian National Research Medical University
Investigators
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Principal Investigator: Roman Lyukmanov, MD Russian Academy of Medical Sciences
More Information
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Additional Information:
Post-stroke Rehabilitation Training with a Motor-Imagery-Based Brain-Computer Interface (BCI)-Controlled Hand Exoskeleton: A Randomized Controlled Multicenter Trial  This link exits the ClinicalTrials.gov site

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Responsible Party: Roman Lyukmanov, Research scientist, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02325947    
Other Study ID Numbers: iMove
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Roman Lyukmanov, Russian Academy of Medical Sciences:
Post stroke hand paresis brain injury
Additional relevant MeSH terms:
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Muscle Weakness
Paresis
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
 Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes