ClinicalTrials.gov
ClinicalTrials.gov Menu

Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton (BCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02550522
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The BCI project falls within the very broad field of brain machine interfaces. Its multiple applications include the compensation of motor deficits. The subject of the present protocol is the first test of the system in man on the compensation of motor deficits by an epidural brain implant enabling an electrocorticogram (EcoG) to be recorded.

Condition or disease Intervention/treatment Phase
Traumatic Tetraplegia With Cervical Cord Injury Device: Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton Not Applicable

Detailed Description:

Injuries to the cervical spine and to its contents, the spinal cord, cause serious neurological deficits, with loss of motor function and sensitivity of the four limbs, resulting in quadriplegia. The level of the lesion separating the area without deficits, above the lesion, from the sub-lesional area depends on the extent of the spine injury (dislocation, fracture or trauma without final displacement), may cause spinal cord injuries of varying severity, which can range from the benign to a complete section that results in complete and irreversible sensorimotor deficits. Lesions from C1 to C4 are often immediately fatal or cause diaphragmatic paralysis (innervated by the phrenic nerve whose roots originate at C4). C4-C5 paraplegia and below are therefore compatible with life as they spare respiratory autonomy, although they lead to severe permanent disabilities, creating a state of severe dependence in subjects who are often young.

The problems created by these patients are those of an extremely heavy individual, family, and societal burden in addition to the individual drama. While paraplegics, by maintaining their motor skills and sensitivity of both upper limbs and back muscles can often reintegrate and find remarkable mobility with wheelchairs, this is not the case of quadriplegics who must be provided with substitutes in order to achieve an acceptable quality of life. This project offers a highly innovative approach by means of a motorized exoskeleton that enables standing, walking and the use of the upper extremities. The validation of the first step of this concept will pave the way for developing increasingly sophisticated exoskeletal neuroprostheses, aimed at giving these patients compatible and ever greater autonomy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
Study Start Date : September 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: BCI
Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton
Device: Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton



Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 4 years after surgery ]
    Complications associated with the chronic implantation of an extradural ECoG measuring implant.


Secondary Outcome Measures :
  1. Patient's level of performance in piloting the degrees of freedom of the exoskeleton [ Time Frame: 4 years after surgery ]
    To test the feasibility of compensation of motor deficits due to spinal trauma by a motorized man-machine interface neuroprosthesis controlled by cortical commands from biomarkers extracted from the ECoG.

  2. Patient's quality of life evaluation [ Time Frame: 4 years after surgery ]
    Perception by the subject of changes in quality of life. Decrease in dependence on care environment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged between 18 and 45 years
  • Stability of neurological deficits in accrued sequelae
  • Lack of adequate compensation for the deficits in terms of quality of life. In other words, the expression by the patient of a need for additional mobility, oriented towards greater autonomy
  • Ambulatory or hospitalized monitoring
  • Fluent in French and able to understand the study procedures, including completing the auto-questionnaires
  • Registered in the French social security scheme
  • Signed informed consent of the patient will be collected before inclusion in the study

Exclusion Criteria:

  • Previous brain surgery,
  • Chronic prescription of anticoagulant treatments,
  • Impaired neuropsychological sequelae from an associated head injury,
  • Depressive syndrome with or without suicide attempt.
  • Alcohol or other substance dependence in the last 12 months, with abuse in the - A complete assessment (neurological and neuropsychological) will be conducted among eligible patients.
  • Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
  • Contraindication to Magnetic resonance imaging (MRI)

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): NCT02550522


Contacts
Contact: Alim-Louis BENABID, MD, PhD + 33 4 38 78 38 14 alimlouis@sfr.fr
Contact: Caroline SANDRE-BALLESTER, PhD + 33 4 38 78 28 51 csandreballester@chu-grenoble.fr

Locations
France
CLINATEC Recruiting
Grenoble, France, 38000
Contact: Alim-Louis BENABID, MD, PhD    + 33 4 38 78 38 14    alimlouis@sfr.fr   
Contact: Caroline SANDRE-BALLESTER, PhD    + 33 4 38 78 28 51    csandreballester@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02550522     History of Changes
Other Study ID Numbers: BCI and Tetraplegia
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Keywords provided by University Hospital, Grenoble:
without associated head injury

Additional relevant MeSH terms:
Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms