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

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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

Tracking Information
First Submitted Date  ICMJE September 11, 2015
First Posted Date  ICMJE September 15, 2015
Last Update Posted Date September 25, 2018
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Number of Participants with Adverse Events [ Time Frame: 4 years after surgery ]
Complications associated with the chronic implantation of an extradural ECoG measuring implant.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
Security of long-term implantation of an extra-dural brain-machine interface in the central region (pre and post rolandic) [ Time Frame: 4 years after surgery ]
Complications associated with the chronic implantation of an extradural ECoG measuring implant.
Change History Complete list of historical versions of study NCT02550522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
  • 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.
  • Decrease in dependence on care environment [ Time Frame: 4 years after surgery ]
    Perception by the subject of changes in quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
Official Title  ICMJE Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Tetraplegia With Cervical Cord Injury
Intervention  ICMJE Device: Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton
Study Arms  ICMJE Experimental: BCI
Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton
Intervention: Device: Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2015)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02550522
Other Study ID Numbers  ICMJE BCI and Tetraplegia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Grenoble
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP