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

• ClinicalTrials.gov Identifier: NCT02550522
• Recruitment Status: Recruiting
• First Posted: September 15, 2015
• Last Update Posted: November 29, 2023
• Sponsor: University Hospital, Grenoble
• Information provided by (Responsible Party): University Hospital, Grenoble

Tracking Information

• First Submitted Date: September 11, 2015
• First Posted Date: September 15, 2015
• Last Update Posted Date: November 29, 2023
• Study Start Date: September 2015
• Estimated Primary Completion Date: September 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Traumatic Tetraplegia With Cervical Cord Injury
• Intervention: Device: Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton

Study Arms

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 *

• Benabid AL, Costecalde T, Eliseyev A, Charvet G, Verney A, Karakas S, Foerster M, Lambert A, Moriniere B, Abroug N, Schaeffer MC, Moly A, Sauter-Starace F, Ratel D, Moro C, Torres-Martinez N, Langar L, Oddoux M, Polosan M, Pezzani S, Auboiroux V, Aksenova T, Mestais C, Chabardes S. An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. Lancet Neurol. 2019 Dec;18(12):1112-1122. doi: 10.1016/S1474-4422(19)30321-7. Epub 2019 Oct 3.
• Larzabal C, Bonnet S, Costecalde T, Auboiroux V, Charvet G, Chabardes S, Aksenova T, Sauter-Starace F. Long-term stability of the chronic epidural wireless recorder WIMAGINE in tetraplegic patients. J Neural Eng. 2021 Sep 9;18(5). doi: 10.1088/1741-2552/ac2003.
• Detection of Error Correlates in the Motor Cortex in a Long Term Clinical Trial of ECoG based Brain Computer Interface DOI: 10.5220/0010227800260034
• Sliwowski M, Martin M, Souloumiac A, Blanchart P, Aksenova T. Decoding ECoG signal into 3D hand translation using deep learning. J Neural Eng. 2022 Mar 31;19(2). doi: 10.1088/1741-2552/ac5d69.
• Moly A, Costecalde T, Martel F, Martin M, Larzabal C, Karakas S, Verney A, Charvet G, Chabardes S, Benabid AL, Aksenova T. An adaptive closed-loop ECoG decoder for long-term and stable bimanual control of an exoskeleton by a tetraplegic. J Neural Eng. 2022 Mar 30;19(2). doi: 10.1088/1741-2552/ac59a0.
• Larzabal C, Auboiroux V, Karakas S, Charvet G, Benabid AL, Chabardes S, Costecalde T, Bonnet S. The Riemannian spatial pattern method: mapping and clustering movement imagery using Riemannian geometry. J Neural Eng. 2021 Apr 8;18(5). doi: 10.1088/1741-2552/abf291.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 14, 2015): 5
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2029
• Estimated Primary Completion Date: September 2028 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Stéphan CHABARDES, MD, PhD; + 33 4 76 76 75 59; SChabardes@chu-grenoble.fr

Contact: Caroline SANDRE-BALLESTER, PhD; + 33 4 38 78 28 51; csandreballester@chu-grenoble.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02550522
• Other Study ID Numbers: BCI and Tetraplegia
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Grenoble
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Grenoble
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Hospital, Grenoble
• Verification Date: November 2023