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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

Tracking Information
First Submitted Date  ICMJE December 8, 2014
First Posted Date  ICMJE December 25, 2014
Last Update Posted Date September 29, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
Change from Baseline in hand paresis level and hand muscle spasticity [ Time Frame: Week 2 ]
ARAT; Fugl-Meyer, Modified Ashworth scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Poststroke/CVA Paresis
Intervention  ICMJE
  • Device: hand exoskeleton, brain-computer interface (BCI),
    Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
    Other Name: mind-machine interface
  • Device: hand exoskeleton, sham BCI
    Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
Study Arms  ICMJE
  • Experimental: Study group
    Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
    Intervention: Device: hand exoskeleton, brain-computer interface (BCI),
  • Sham Comparator: Placebo group
    Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
    Intervention: Device: hand exoskeleton, sham BCI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2017)
75
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2014)
120
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02325947
Other Study ID Numbers  ICMJE iMove
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Roman Lyukmanov, Russian Academy of Medical Sciences
Study Sponsor  ICMJE Russian Academy of Medical Sciences
Collaborators  ICMJE Pirogov Russian National Research Medical University
Investigators  ICMJE
Principal Investigator: Roman Lyukmanov, MD Russian Academy of Medical Sciences
PRS Account Russian Academy of Medical Sciences
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP