Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients

Poststroke/CVA Paresis Clinical Trial

— iMove  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325947
• Other study ID #: iMove
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: September 27, 2017
• Start date: January 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Poststroke/CVA Paresis

Intervention

Device:
• hand exoskeleton, brain-computer interface (BCI),
Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
• hand exoskeleton, sham BCI
Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)

Locations

Country	Name	City	State
Russian Federation	Research Center of Neurology of RAMS	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences	Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in hand paresis level and hand muscle spasticity	ARAT; Fugl-Meyer, Modified Ashworth scale	Week 2
Secondary	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

External Links

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