Efficacy of Hand Exoskeleton Controlled by BCI in Post St... | NCT02325947

Studies
Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients

NCT02325947

Sponsor

Russian Academy of Medical Sciences

Status

Completed

Last Update Posted

Sep 29, 2017Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

Poststroke/CVA Paresis

Interventions

hand exoskeleton, brain-computer interface (BCI),
hand exoskeleton, sham BCI

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Dec 8, 2014

First Submission Date that Met QC Criteria

Dec 19, 2014

First Posted Date

Dec 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2017

Last Update Posted Date

Sep 29, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roman Lyukmanov, Research scientist, Russian Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Russian Academy of Medical SciencesOTHER

Collaborators

Name	Class
Pirogov Russian National Research Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes	Device: hand exoskeleton, brain-computer interface (BCI),
Placebo group	Sham Comparator	Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)	Device: hand exoskeleton, sham BCI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hand exoskeleton, brain-computer interface (BCI),	Device	Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes	Study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roman Lyukmanov, MD	Russian Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Center of Neurology of RAMS		Moscow		125367	Russia

References Module

Citations

Not provided

ID	Term
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies