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 : May 11, 2021
|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|
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)|
|Official Title:||Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2026|
|Estimated Study Completion Date :||June 2027|
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
- Number of Participants with Adverse Events [ Time Frame: 4 years after surgery ]Complications associated with the chronic implantation of an extradural ECoG measuring implant.
- 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.
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
|Contact: Alim-Louis BENABID, MD, PhD||+ 33 4 38 78 38 firstname.lastname@example.org|
|Contact: Caroline SANDRE-BALLESTER, PhD||+ 33 4 38 78 28 email@example.com|