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Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients

NCT ID: NCT02325947

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Poststroke/CVA Paresis

Keywords

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Post stroke hand paresis brain injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Study group

Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes

Group Type EXPERIMENTAL

hand exoskeleton, brain-computer interface (BCI),

Intervention Type DEVICE

Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes

Placebo group

Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)

Group Type SHAM_COMPARATOR

hand exoskeleton, sham BCI

Intervention Type DEVICE

Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)

Interventions

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hand exoskeleton, brain-computer interface (BCI),

Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes

Intervention Type DEVICE

hand exoskeleton, sham BCI

Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)

Intervention Type DEVICE

Other Intervention Names

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mind-machine interface

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pirogov Russian National Research Medical University

OTHER

Sponsor Role collaborator

Russian Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Roman Lyukmanov

Research scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roman Lyukmanov, MD

Role: PRINCIPAL_INVESTIGATOR

Russian Academy of Medical Sciences

Locations

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Research Center of Neurology of RAMS

Moscow, , Russia

Site Status

Countries

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Russia

Related Links

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https://www.frontiersin.org/articles/10.3389/fnins.2017.00400/full

Post-stroke Rehabilitation Training with a Motor-Imagery-Based Brain-Computer Interface (BCI)-Controlled Hand Exoskeleton: A Randomized Controlled Multicenter Trial

Other Identifiers

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iMove

Identifier Type: -

Identifier Source: org_study_id