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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Brain-Computer Interface control of robotic arms.
MERCURY v2.0 robotic arms
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injuries focused on measuring Robotics, Cerebral cortex, Brain waves, Electroencephalography, Rehabilitation, Brain-Computer Interfaces

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lab of Medical Physics, Faculty of Medicine, Aristolte University of Thessaloniki

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Complete Injury

Incomplete Injury

Non-cervical injury

Healthy participants

Arm Description

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.

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

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

Healthy participants, age and sex matched to those of the other Arms. Brain-Computer Interface control of robotic arms. MERCURY v2.0 robotic arms

Outcomes

Primary Outcome Measures

BCI control (yes/no). (ability of participants to modulate brainwave activity in order to achieve control of the BCI)
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)
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)
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)
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).

Full Information

First Posted
May 5, 2015
Last Updated
February 13, 2020
Sponsor
Aristotle University Of Thessaloniki
Collaborators
Cervical Spine Research Society
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1. Study Identification

Unique Protocol Identification Number
NCT02443558
Brief Title
Brainwave Control of a Wearable Robotic Arm for Rehabilitation and Neurophysiological Study in Cervical Spine Injury
Acronym
CSI:Brainwave
Official Title
Brainwave Control of a Wearable Robotic Arm for Rehabilitation and Neurophysiological Study in Cervical Spine Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
Cervical Spine Research Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Robotics, Cerebral cortex, Brain waves, Electroencephalography, Rehabilitation, Brain-Computer Interfaces

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complete Injury
Arm Type
Experimental
Arm Description
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.
Arm Title
Incomplete Injury
Arm Type
Experimental
Arm Description
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
Arm Title
Non-cervical injury
Arm Type
Active Comparator
Arm Description
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
Arm Title
Healthy participants
Arm Type
Active Comparator
Arm Description
Healthy participants, age and sex matched to those of the other Arms. Brain-Computer Interface control of robotic arms. MERCURY v2.0 robotic arms
Intervention Type
Other
Intervention Name(s)
Brain-Computer Interface control of robotic arms.
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
MERCURY v2.0 robotic arms
Other Intervention Name(s)
robotic arms
Intervention Description
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.
Primary Outcome Measure Information:
Title
BCI control (yes/no). (ability of participants to modulate brainwave activity in order to achieve control of the BCI)
Description
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).
Time Frame
1 month after first participation in a BCI session.
Secondary Outcome Measure Information:
Title
Initial Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)
Description
Daily functionality as measured by the Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III).
Time Frame
6 months after first participation in a BCI session.
Title
Long-term Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)
Description
Daily functionality as measured by the Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III).
Time Frame
1 year after first participation in a BCI session.
Title
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)
Description
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).
Time Frame
6 months after first participation in a BCI session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiotis Bamidis, PhD
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lab of Medical Physics, Faculty of Medicine, Aristolte University of Thessaloniki
City
Thessaloníki
State/Province
Thessaloniki
ZIP/Postal Code
54124
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29163098
Citation
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.
Results Reference
background
PubMed Identifier
27241945
Citation
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.
Results Reference
background
PubMed Identifier
28948168
Citation
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.
Results Reference
result
Citation
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
Results Reference
result
PubMed Identifier
29853852
Citation
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.
Results Reference
derived

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

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