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

February 13, 2020 updated by: Panos Bamidis, Aristotle University Of Thessaloniki

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • robotic arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 month after first participation in a BCI session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)
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).
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)
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).
6 months after first participation in a BCI session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Cervical Spine Research Society

Investigators

  • Principal Investigator: Panagiotis Bamidis, PhD, Aristotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2016

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (ESTIMATE)

May 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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