Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton (BCI)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Caroline SANDRE-BALLESTER, PhD; Stéphan CHABARDES, MD, PhD
Data sourced from clinicaltrials.gov
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