Clinical trial NCT02550522: Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
Official title: Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Tetraplegia with Cervical Cord Injury
Keywords: without associated head injury
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 4 years after surgery
Secondary outcomes:
measure: Patient's level of performance in piloting the degrees of freedom of the exoskeleton
timeFrame: 4 years after surgery
measure: Patient's quality of life evaluation
timeFrame: 4 years after surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CLINATEC
Study officials:
References:
citation: 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.
citation: 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.
citation: Detection of Error Correlates in the Motor Cortex in a Long Term Clinical Trial of ECoG based Brain Computer Interface DOI: 10.5220/0010227800260034
citation: 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.
citation: 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.
citation: 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.