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

Primary Purpose

Traumatic Tetraplegia With Cervical Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Tetraplegia With Cervical Cord Injury focused on measuring without associated head injury

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy 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)

Sites / Locations

  • CLINATECRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BCI

Arm Description

Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events
Complications associated with the chronic implantation of an extradural ECoG measuring implant.

Secondary Outcome Measures

Patient's level of performance in piloting the degrees of freedom of the exoskeleton
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
Perception by the subject of changes in quality of life. Decrease in dependence on care environment.

Full Information

First Posted
September 11, 2015
Last Updated
October 12, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02550522
Brief Title
Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
Acronym
BCI
Official Title
Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
April 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Tetraplegia With Cervical Cord Injury
Keywords
without associated head injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCI
Arm Type
Experimental
Arm Description
Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton
Intervention Type
Device
Intervention Name(s)
Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
Complications associated with the chronic implantation of an extradural ECoG measuring implant.
Time Frame
4 years after surgery
Secondary Outcome Measure Information:
Title
Patient's level of performance in piloting the degrees of freedom of the exoskeleton
Description
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.
Time Frame
4 years after surgery
Title
Patient's quality of life evaluation
Description
Perception by the subject of changes in quality of life. Decrease in dependence on care environment.
Time Frame
4 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphan CHABARDES, MD, PhD
Phone
+ 33 4 76 76 75 59
Email
SChabardes@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline SANDRE-BALLESTER, PhD
Phone
+ 33 4 38 78 28 51
Email
csandreballester@chu-grenoble.fr
Facility Information:
Facility Name
CLINATEC
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphan CHABARDES, MD, PhD
Phone
+ 33 4 76 76 75 59
Email
SChabardes@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Caroline SANDRE-BALLESTER, PhD
Phone
+ 33 4 38 78 28 51
Email
csandreballester@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Stéphan CHABARDES, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31587955
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.
Results Reference
background
PubMed Identifier
34425566
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
35287119
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.
Results Reference
derived
PubMed Identifier
35234665
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.
Results Reference
derived
PubMed Identifier
33770779
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.
Results Reference
derived

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Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton

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