Traumatic Tetraplegia with Cervical Cord InjuryBCINCT02550522
Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
A study testing Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton in people with Traumatic Tetraplegia with Cervical Cord Injury, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Traumatic Tetraplegia with Cervical Cord Injury
- What is being tested?
- Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Apr 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CLINATEC
Grenoble, 38000
Stéphan CHABARDES, MD, PhD, + 33 4 76 76 75 59, SChabardes@chu-grenoble.fr
Caroline SANDRE-BALLESTER, PhD, + 33 4 38 78 28 51, csandreballester@chu-grenoble.fr
About this study
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.
Read the 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.
- Being tested
- Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton
- Keywords
- without associated head injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeletonDevice
| Study group | Role | What they receive |
|---|---|---|
| BCI | Experimental | Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton Receives: Device: Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Complications associated with the chronic implantation of an extradural ECoG measuring implant.
Measured: 4 years after surgery
Secondary outcomes (2)
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.
Measured: 4 years after surgery
Patient's quality of life evaluation
Perception by the subject of changes in quality of life. Decrease in dependence on care environment.
Measured: 4 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2033 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Traumatic Tetraplegia with Cervical Cord InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550522
- Sponsor's protocol ID
- BCI and Tetraplegia
- Acronym
- BCI
- Status last verified
- Dec 2024
- First submitted
- 11 Sep 2015
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 31587955Larzabal 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.
PubMed 34425566Detection of Error Correlates in the Motor Cortex in a Long Term Clinical Trial of ECoG based Brain Computer Interface DOI: 10.5220/0010227800260034
Bellicha A, Struber L, Pasteau F, Juillard V, Devigne L, Karakas S, Chabardes S, Babel M, Charvet G. Depth-sensor-based shared control assistance for mobility and object manipulation: toward long-term home-use of BCI-controlled assistive robotic devices. J Neural Eng. 2025 Feb 14;22(1). doi: 10.1088/1741-2552/adae36.
PubMed 39854845Sliwowski M, Martin M, Souloumiac A, Blanchart P, Aksenova T. Impact of dataset size and long-term ECoG-based BCI usage on deep learning decoders performance. Front Hum Neurosci. 2023 Mar 16;17:1111645. doi: 10.3389/fnhum.2023.1111645. eCollection 2023.
PubMed 37007675Sliwowski 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.
PubMed 35287119Moly 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.
PubMed 35234665Larzabal 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.
PubMed 33770779
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
- ClinicalTrials.gov ID
- NCT02550522
- Acronym / sponsor ID
- BCI / BCI and Tetraplegia
- Keywords
- without associated head injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2033 (estimated)
- Study completion
- Apr 2033 (estimated)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCI | Experimental | Device: Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeletonBrain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton | Device | BCI |
Primary outcome
Number of Participants with Adverse Events
Time frame: 4 years after surgery
Complications associated with the chronic implantation of an extradural ECoG measuring implant.
2 secondary outcomes
Patient's level of performance in piloting the degrees of freedom of the exoskeleton
Time frame: 4 years after surgery
Patient's quality of life evaluation
Time frame: 4 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 31587955Benabid 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.
- Background: PubMed 34425566Larzabal 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.
- BackgroundDetection of Error Correlates in the Motor Cortex in a Long Term Clinical Trial of ECoG based Brain Computer Interface DOI: 10.5220/0010227800260034
- Derived from this study: PubMed 39854845Bellicha A, Struber L, Pasteau F, Juillard V, Devigne L, Karakas S, Chabardes S, Babel M, Charvet G. Depth-sensor-based shared control assistance for mobility and object manipulation: toward long-term home-use of BCI-controlled assistive robotic devices. J Neural Eng. 2025 Feb 14;22(1). doi: 10.1088/1741-2552/adae36.
- Derived from this study: PubMed 37007675Sliwowski M, Martin M, Souloumiac A, Blanchart P, Aksenova T. Impact of dataset size and long-term ECoG-based BCI usage on deep learning decoders performance. Front Hum Neurosci. 2023 Mar 16;17:1111645. doi: 10.3389/fnhum.2023.1111645. eCollection 2023.
- Derived from this study: PubMed 35287119Sliwowski 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.
- Derived from this study: PubMed 35234665Moly 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.
- Derived from this study: PubMed 33770779Larzabal 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton in people with Traumatic Tetraplegia with Cervical Cord Injury, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphan CHABARDES, MD, PhD (+ 33 4 76 76 75 59, SChabardes@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: 4 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550522, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.