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

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

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.

Study Overview

• Status: Completed
• Conditions: Poststroke/CVA Paresis
• Intervention / Treatment: Device: hand exoskeleton, brain-computer interface (BCI),; Device: hand exoskeleton, sham BCI

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: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 125367
    • Research Center of Neurology of RAMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in hand paresis level and hand muscle spasticity	ARAT; Fugl-Meyer, Modified Ashworth scale	Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term changes from Baseline in hand paresis level and hand muscle spasticity	ARAT; Fugl-Meyer, Modified Ashworth scale	week 4, week 12, week 24

Collaborators and Investigators

• Sponsor: Russian Academy of Medical Sciences
• Collaborators: Pirogov Russian National Research Medical University
• Investigators: Principal Investigator: Roman Lyukmanov, MD, Russian Academy of Medical Sciences

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 25, 2014

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Post stroke hand paresis brain injury
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Paresis
• Other Study ID Numbers: iMOVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED