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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 : Completed
First Posted : May 14, 2015
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Cervical Spine Research Society
Information provided by (Responsible Party):
Panos Bamidis, Aristotle University Of Thessaloniki

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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:

  1. A clinical study for rehabilitation of patients with Cervical Spinal Cord Injury (CSCI), using a Brain-Computer Interface (BCI) controlled robotic arms device.
  2. 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:

  1. The investigators aim to develop, test and optimize a mountable robotic arm controlled with wireless BCI.
  2. The investigators aim to develop and validate self-paced neuro-rehabilitation protocols for patients with CSCI.
  3. 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
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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
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 :
  1. 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).

  2. 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).

  3. 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
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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
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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
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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
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Principal Investigator: Panagiotis Bamidis, PhD Aristotle University Of Thessaloniki
More Information
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Publications of Results:
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:

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

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Responsible Party: Panos Bamidis, Assistant Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02443558    
Other Study ID Numbers: 90886
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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