Brainwave Control of a Wearable Robotic Arm for Rehabilitation and Neurophysiological Study in Cervical Spine Injury
CSI:Brainwave
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2015
CompletedFirst Posted
Study publicly available on registry
May 14, 2015
CompletedStudy Start
First participant enrolled
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFebruary 17, 2020
February 1, 2020
2 years
May 5, 2015
February 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
1 month after first participation in a BCI session.
Secondary Outcomes (3)
Initial Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)
6 months after first participation in a BCI session.
Long-term Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)
1 year after first participation in a BCI session.
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)
6 months after first participation in a BCI session.
Study Arms (4)
Complete Injury
EXPERIMENTALPatients 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.
Incomplete Injury
EXPERIMENTALPatients 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
Non-cervical injury
ACTIVE COMPARATORPatients 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
ACTIVE COMPARATORHealthy participants, age and sex matched to those of the other Arms. Brain-Computer Interface control of robotic arms. MERCURY v2.0 robotic arms
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lab of Medical Physics, Faculty of Medicine, Aristolte University of Thessaloniki
Thessaloniki, Thessaloniki, 54124, Greece
Related Publications (5)
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.
PMID: 29163098BACKGROUNDAthanasiou 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.
PMID: 27241945BACKGROUNDAthanasiou 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.
PMID: 28948168RESULTAthanasiou 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
RESULTAthanasiou 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.
PMID: 29853852DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Panagiotis Bamidis, PhD
Aristotle University Of Thessaloniki
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 5, 2015
First Posted
May 14, 2015
Study Start
December 15, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
February 17, 2020
Record last verified: 2020-02