Brainwave Control of a Wearable Robotic Arm for Rehabilitation and Neurophysiological Study in Cervical Spine Injury (CSI:Brainwave)

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ClinicalTrials.gov Identifier: NCT02443558

Recruitment Status : Active, not recruiting

First Posted : May 14, 2015

Last Update Posted : January 10, 2019

Sponsor:

Collaborator:

Cervical Spine Research Society

Information provided by (Responsible Party):

Panos Bamidis, Aristotle University Of Thessaloniki

Study Description

Brief Summary:

CSI:Brainwave is a multidisciplinary neurophysiological project, developed by the Lab of Medical Physics, School of Medicine, Aristotle University of Thessaloniki and supported by two Neurosurgical Departments. The project officially commenced on April 2014 and the first year was awarded the 2013 Mario Boni Research Grant by the Cervical Spine Research Society-European Section (CSRS-ES). The website for the project can be accessed at http://medphys.med.auth.gr/content/csi-brainwave.

The investigation's primary objectives include the development, testing and optimization of a mountable robotic arm controlled with wireless Brain-Computer Interface, the development and validation of a self-paced neuro-rehabilitation protocol for patients with Cervical Spinal Cord Injury and the study of cortical activity in acute and chronic spinal cord injury.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries	Other: Brain-Computer Interface control of robotic arms. Device: MERCURY v2.0 robotic arms	Not Applicable

Detailed Description:

CSI:Brainwave project's full title is <Brainwave control of a wearable robotic arm for rehabilitation and neurophysiological study in Cervical Spine Injury> . It is a multidisciplinary neurophysiological project, developed by the Lab of Medical Physics and supported by two Neurosurgical Departments.

The CSI:Brainwave project involves:

A clinical study for rehabilitation of patients with Cervical Spinal Cord Injury (CSCI), using a Brain-Computer Interface (BCI) controlled robotic arms device.
A secondary off-line neurophysiological analysis of cortical activation, connectivity and plasticity in patients with CSCI undergoing motor imagery (MI) practice.

Milestones of the study:

The investigators aim to develop, test and optimize a mountable robotic arm controlled with wireless BCI.
The investigators aim to develop and validate self-paced neuro-rehabilitation protocols for patients with CSCI.
The investigators aim to identify and study the neurophysiological functionality and alteration of cortical activity in acute and chronic CSCI.

The CSI: Brainwave project aims at allowing patients suffering from tetraplegia due to CSCI to perform brainwave modulation, practicing Kinesthetic Motor Imagery (KMI) and Visual Motor Imagery (VMI), as well as offering neurofeedback with the form of control of a 6-degree-of-freedom, anthropomorphic bimanual robotic arms device. The project aims at demonstrating the added value of neurofeedback for rehabilitation and/or motor restoration of CSCI patients and allow for elaborate recordings of motor-related brain activity during motor tasks of the upper and lower extremities.

The robotic arms are designed to mount on a frame that acts as a docking space for the participants' armchair/wheelchair and will be directly controlled by the participants using a BCI module. The investigators aim to further modify the robotic device in order to render it mountable on the participants' actual arms.

The largest portion of the first project year was devoted to the development of robotics and the Brain-Computer Interface module of the study. The MERCURY v2.0 robotic arms is a non-commercial 6-degree-of-freedom anthropomorphic bimanual robotic arms device that was built and developed by the research team of the Medical Physics Lab. The robot was further engineered to accommodate the needs of the CSI:Brainwave project. The investigators aim to use the Emotiv EPOC wireless EEG headset and software for the development and control of the BCI module in this study.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Brainwave Control of a Wearable Robotic Arm for Rehabilitation and Neurophysiological Study in Cervical Spine Injury
Actual Study Start Date :	December 15, 2016
Estimated Primary Completion Date :	July 31, 2019
Estimated Study Completion Date :	January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neck Injuries and Disorders Rehabilitation Spinal Cord Injuries Spine Injuries and Disorders

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Complete Injury Patients suffering from complete injury at the cervical spinal cord level (ASIA Impairment Scale A). Brain-Computer Interface control of robotic arms. MERCURY v2.0 robotic arms.	Other: Brain-Computer Interface control of robotic arms. The patients will be trained to modulate self-paced Visual Motor Imagery (VMI) and Kinesthetic Motor Imagery (KMI) under EEG recording in order to achieve BCI-control of a custom-built bimanual arms robot (MERCURY v2.0). In KMI they will be asked to modulate brain waves in order to learn to control the BCI and in VMI they will additionally be projected a visual cue (representation of the intended movement). Device: MERCURY v2.0 robotic arms MERCURY v2.0 robotic arms is a non-commercial 6-degree-of-freedom anthropomorphic bimanual robotic arms device that was built and developed by the research team of the Medical Physics Lab. Other Name: robotic arms
Experimental: Incomplete Injury Patients suffering from incomplete injury at the cervical spinal cord level (ASIA Impairment Scale B,C,D,E). Brain-Computer Interface control of robotic arms. MERCURY v2.0 robotic arms	Other: Brain-Computer Interface control of robotic arms. The patients will be trained to modulate self-paced Visual Motor Imagery (VMI) and Kinesthetic Motor Imagery (KMI) under EEG recording in order to achieve BCI-control of a custom-built bimanual arms robot (MERCURY v2.0). In KMI they will be asked to modulate brain waves in order to learn to control the BCI and in VMI they will additionally be projected a visual cue (representation of the intended movement). Device: MERCURY v2.0 robotic arms MERCURY v2.0 robotic arms is a non-commercial 6-degree-of-freedom anthropomorphic bimanual robotic arms device that was built and developed by the research team of the Medical Physics Lab. Other Name: robotic arms
Active Comparator: Non-cervical injury Patients suffering from complete or incomplete injury of the spinal cord at a level other than the cervical (thoracic or lumbar). Brain-Computer Interface control of robotic arms. MERCURY v2.0 robotic arms	Other: Brain-Computer Interface control of robotic arms. The patients will be trained to modulate self-paced Visual Motor Imagery (VMI) and Kinesthetic Motor Imagery (KMI) under EEG recording in order to achieve BCI-control of a custom-built bimanual arms robot (MERCURY v2.0). In KMI they will be asked to modulate brain waves in order to learn to control the BCI and in VMI they will additionally be projected a visual cue (representation of the intended movement). Device: MERCURY v2.0 robotic arms MERCURY v2.0 robotic arms is a non-commercial 6-degree-of-freedom anthropomorphic bimanual robotic arms device that was built and developed by the research team of the Medical Physics Lab. Other Name: robotic arms
Active Comparator: Healthy participants Healthy participants, age and sex matched to those of the other Arms. Brain-Computer Interface control of robotic arms. MERCURY v2.0 robotic arms	Other: Brain-Computer Interface control of robotic arms. The patients will be trained to modulate self-paced Visual Motor Imagery (VMI) and Kinesthetic Motor Imagery (KMI) under EEG recording in order to achieve BCI-control of a custom-built bimanual arms robot (MERCURY v2.0). In KMI they will be asked to modulate brain waves in order to learn to control the BCI and in VMI they will additionally be projected a visual cue (representation of the intended movement). Device: MERCURY v2.0 robotic arms MERCURY v2.0 robotic arms is a non-commercial 6-degree-of-freedom anthropomorphic bimanual robotic arms device that was built and developed by the research team of the Medical Physics Lab. Other Name: robotic arms

Outcome Measures

Primary Outcome Measures :

BCI control (yes/no). (ability of participants to modulate brainwave activity in order to achieve control of the BCI) [ Time Frame: 1 month after first participation in a BCI session. ]
The ability of participants to modulate brainwave activity in order to achieve control of the BCI.

BCI control is evaluated as achieved or not (there are cases of BCI-illiteracy when the participants cannot modulate their brainwaves in order to control the BCI).

Secondary Outcome Measures :

Initial Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III) [ Time Frame: 6 months after first participation in a BCI session. ]
Daily functionality as measured by the Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III).
Long-term Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III) [ Time Frame: 1 year after first participation in a BCI session. ]
Daily functionality as measured by the Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III).
BCI performance (classification accuracy (percentage of voluntary non-erroneous commands to overall number of detected commands) and by bit rate (number of commands per minute) [ Time Frame: 6 months after first participation in a BCI session. ]
Achieved performance on BCI at conclusion of BCI sessions for each participant. Measured by classification accuracy (percentage of voluntary non-erroneous commands to overall number of detected commands) and by bit rate (number of commands per minute).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	14 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Clinical diagnosis of Spinal Cord Injury (SCI evaluated by ASIA Impairment Scale).
Healthy participants (age and gender matched to SCI patients)
Sufficient documentation of the injury in case of patients (neurological examination, MRI scan of the injury level, optional additional CT or x-rays).
Signed informed consent (patients and healthy individuals).

Exclusion Criteria:

Other neurological condition that has a possibility to significantly affect the neurological status of the participants (or) the ability to control a BCI (or) the neurophysiological recordings:
- Traumatic brain injury
- Central Nervous System tumors
- Multiple Sclerosis
- Amyotrophic Lateral Sclerosis
- Parkinson's disease
- Refractory Epilepsy
Participation during the last 3months in an another interventional study, the effects of which could affect this study's observations.
Other grave medical condition that could affect the participation (or) the safety of the participants:
- Cardiac deficiency
- Pulmonary deficiency
Hearing and visual impairments that can affect the participant's understanding of the intervention and performance.
Illegal drug use
Chronic alcoholism

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443558

Locations


Greece
Lab of Medical Physics, Faculty of Medicine, Aristolte University of Thessaloniki
Thessaloníki, Thessaloniki, Greece, 54124

Sponsors and Collaborators

Aristotle University Of Thessaloniki

Cervical Spine Research Society

Investigators


Principal Investigator:	Panagiotis Bamidis, PhD	Aristotle University Of Thessaloniki

More Information

Publications of Results:

Athanasiou A, Xygonakis I, Pandria N, Kartsidis P, Arfaras G, Kavazidi KR, Foroglou N, Astaras A, Bamidis PD. Towards Rehabilitation Robotics: Off-the-Shelf BCI Control of Anthropomorphic Robotic Arms. Biomed Res Int. 2017;2017:5708937. doi: 10.1155/2017/5708937. Epub 2017 Aug 29.

Athanasiou A, Arfaras G, Pandria N, Xygonakis I, Foroglou N, Astaras A, Bamidis PD. Wireless brain-robot interface: user perception and performance assessment of spinal cord injury patients. Wireless Communication and Mobile Computing, 2017: 2986423, 2017 https://doi.org/10.1155/2017/2986423

Other Publications:

Athanasiou A, Klados MA, Pandria N, Foroglou N, Kavazidi KR, Polyzoidis K, Bamidis PD. A Systematic Review of Investigations into Functional Brain Connectivity Following Spinal Cord Injury. Front Hum Neurosci. 2017 Oct 25;11:517. doi: 10.3389/fnhum.2017.00517. eCollection 2017.

Athanasiou A, Klados MA, Styliadis C, Foroglou N, Polyzoidis K, Bamidis PD. Investigating the Role of Alpha and Beta Rhythms in Functional Motor Networks. Neuroscience. 2018 May 15;378:54-70. doi: 10.1016/j.neuroscience.2016.05.044. Epub 2016 May 27.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Athanasiou A, Terzopoulos N, Pandria N, Xygonakis I, Foroglou N, Polyzoidis K, Bamidis PD. Functional Brain Connectivity during Multiple Motor Imagery Tasks in Spinal Cord Injury. Neural Plast. 2018 May 2;2018:9354207. doi: 10.1155/2018/9354207. eCollection 2018.


Responsible Party:	Panos Bamidis, Assistant Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT02443558 History of Changes
Other Study ID Numbers:	90886
First Posted:	May 14, 2015 Key Record Dates
Last Update Posted:	January 10, 2019
Last Verified:	January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Panos Bamidis, Aristotle University Of Thessaloniki:


Robotics Cerebral cortex Brain waves	Electroencephalography Rehabilitation Brain-Computer Interfaces

Additional relevant MeSH terms:


Wounds and Injuries Spinal Cord Injuries Spinal Injuries Spinal Cord Diseases	Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Back Injuries

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