Intervention StudyI-GRIPNCT07642804
Virtual Reality Assessment of Control Interfaces for the Use a Neuroprosthesis in Individuals With Tetraplegia
A study of Intervention Study, run by Centre Bouffard Vercelli - USSAP at 1 site in France.
Trial summary
With a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intervention Study
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2026to 27 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury defined by an AIS A, B or score (AIS A, B): complete or incomplete motor deficit below the lesion. This is a standard for describing spinalcord injuries that has been internationally agreed upon.
- Spinal cord injury at the neurological level > C7
- Age greater than or equal to 18 and less than or equal to 80 years
- A history of more than 3 months of neurological stability, with no changes in muscle testing.
- Participants capable of following instructions for testing and providing feedback on the use of the device.
- Participants who have signed the informed consent form to participate in the study after being fully informed.
- Participants affiliated with a social security system (either as a beneficiary or a dependent), excluding those covered by State Medical Aid (AME).
Who cannot join
- • Participant deprived of liberty (by judicial or administrative decision).
- Adult participants are under legal protection or unable to provide informed consent.
- Participation in another ongoing clinical trial.
- Unstable psychiatric condition.
- Severe cognitive impairment.
- Unstable acute medical condition
- Insufficient proficiency in spoken and written French.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relevance of Virtual Reality Assessment of Control Interfaces for a Neuroprosthesis That Stimulates the Upper Limbs of Quadriplegic Individuals
With a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices. The operating principle of the device we are interested in is to provide a set of predefined functional electrical stimulation (FES) configurations that activate specific hand movements (hand opening, palmar grasp, key grip, etc.), from which the user selects the one that is suitable for performing a task. The user control is usually based on commands from the contralateral limb (pressing a button, shoulder movement, or voluntary muscle contractions). These stereotypical and unintuitive commands hinder any possibility of bimanual tasks. Hands-free voice interfaces have been tested but have contextual limitations, particularly in terms of discretion or usability for certain activities such as eating. Furthermore, it is difficult to evaluate the performance of control interfaces and adjust them prior to the implantation of the stimulation neuroprosthesis. The aim of the I-GRIP project is to establish a methodology that is sufficiently realistic to enable people to envision their future use of a neuroprosthesis. Such a tool would also enable future candidates for implantation to better understand the device's potential. This approach would also make it possible to customize the technology prior to implantation (choice and adjustment of control interfaces, training, configuration of algorithms for analyzing movements evoked by stimulation, etc.).
Our main hypothesis is that two control interfaces (HMI1 and HMI2) will allow the user to control the completion of a grasping task (approach, grasp, hold) for each target object in the virtual environment simulating electrical stimulation of the forearm muscles.
Read the detailed description
Immersive, semi-immersive, or non-immersive VR has mainly been used for therapeutic rehabilitation purposes in patients with spinal cord injuries who have motor impairments in their upper limbs. A recent literature review in 2024 highlights a strong trend emerging from the analysis of all publications on the subject, namely an analytical gain in strength with no impact on manual dexterity, this gain being all the more significant the longer the training lasted (> 15 hours in total). In the field of functional electrical muscle stimulation, which is of interest to us here, Ajiboye et al. 2017 proposed post-implantation training of an upper limb (UL) stimulation neuroprosthesis in a quadriplegic patient under the control of a Brain Computer Interface (BCI) and compared object grasping performance in immersive VR and non-VR. Given that VR training was longer than non-VR training, movements were found to be smoother and more precise in VR. The uniqueness of this experiment lies in having established proof of concept around a subject's ability to control single and multi-coordinated movements with 80 to 100% accuracy using their thoughts, first using a virtual upper limb (UL) and then their own UL activated by FES to drink a cup of coffee and bring food to their mouth. It also highlighted the real value of immersive virtual reality in learning movements.
A recent publication of a clinical case study focused on the use of a Leap Motion optical hand tracking controller in a semi-immersive environment [Ahmed Al Nattah 2024]. Leap Motion, which is mainly used in kinematic assessments, is introduced in this publication for the purpose of rehabilitating the hand of an incomplete quadriplegic participant equipped with sensors and invited to perform exercises of increasing difficulty in custom-built video games offering both visual and auditory feedback. Beyond the promising therapeutic benefits observed in this single case study, this semi-immersive experience can be transposed into full immersion in applications such as the optimization and customization of neuroprosthesis control interfaces. VR is playing an increasingly decisive role in movement rehabilitation. It is part of the therapeutic arsenal that now aims to offer a fun, meaningful, and motivating approach to encourage the repetition of gestures and movements and, in fact, learning. However, its use as a tool for designing and evaluating the performance of assistive technology control interfaces has been little explored in studies, which justifies the approach adopted in this project.
With a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices. Such an environment would ultimately enable future users to prepare for the use of these devices and to project themselves into their use. This approach would also make it possible to customize the technology prior to implantation (choice and adjustment of control interfaces, training, configuration of algorithms for analyzing movements evoked by stimulation, etc.). In general, it is important to advance control interfaces to improve their ergonomics and usability. Here, we wish to show that virtual reality allows participants to realistically project themselves into an experience of using a neuroprosthesis that controls wrist extension and finger flexion/extension movements.
Participants will be equipped with a virtual reality headset that will project a virtual scene with various everyday objects and a representation of their hand. They will have to move their arm towards one of the objects in the scene, then trigger hand movements using one of the available control interfaces to grasp the object and manipulate it. Two methods of controlling the opening and closing movements of the fingers will be tested: HMI1: two physical buttons activated by pressing with the opposite hand to send commands, and HMI2 - shared control: the reaching movement of the arm towards the object is tracked using a video camera and automatically select the appropriate opening and gripping movements. HMI1 therefore requires a stereotypical action (pressing a button), while HMI2 allows automatic selection of grasping movements by observing the natural movements of approaching the object, which are observed by a camera and interpreted by an algorithm.
The experimental aspects of the study will be conducted over 2 sessions:
- (V1) Selection Visit: The selection visit will be conducted by the coordinating investigator, who will monitor the participant throughout the trial.
- (V2) Inclusion Visit: This visit will include: Clinical examination Collection of the signed consent form
- (V3 to V4) Experimental Visits: V3 (session 1): Taking measurements of the user to customize the models used for the virtual environment (2 hours max) V4 (session 2): Virtual immersion experiment (2 hours max)
- (V5) End-of-Study Visit: This final visit will consist of a clinical and psychological follow-up consultation to ensure the absence of any adverse effects.
- Conditions
- Intervention Study
- Being tested
- Virtual reality used as a simulation tool to evaluate and optimize the use of control interfaces
- Keywords
- tetraplegia, upper limb, functional electrical stimulation, neuroprosthesis, virtual reality, control interfaces
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality used as a simulation tool to evaluate and optimize the use of control interfacesDevice
With a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices.
| Study group | Role | What they receive |
|---|---|---|
| Patients with complete tetraplegia AIS A or B, with a neurological level ≥ C7 | Experimental | Not described Receives: Device: Virtual reality used as a simulation tool to evaluate and optimize the use of control interfaces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy indicators
Success rate (%) of the task (approach the object, grasp it with the dedicated grip, hold it for 5 seconds) over 10 repetitions for the each control modality. The expected success rate is at least 90% over all 10 repetitions for each control modality after a short learning phase.
Measured: At Day 1
Secondary outcomes (5)
Time workload indicators
Task execution time (seconds) for each of the HMIs
Measured: At day 1
Indicators of satisfaction, comfort, pleasure of use and subjective workload
Enjoyability of the control interface, reflecting the user's mood, motivation, or frustration.
Evaluation criterion: For each HMI, after 10 repetitions, appropriate section of the questionnaire National Aeronautics and Space Administration Task Load Index (NASA-TLX). For each item, the score min is 0 and max 100.
Measured: At day 1
Indicators of satisfaction, comfort, pleasure of use and subjective workload
Measuring the patient experience Evaluation criterion: For each HMI, after 10 repetitions, appropriate section of the questionnaire PREMs.
Measured: At day 1
Indicator of appropriation: quality of the embodiement in the VR environment Appropriation
Appropriation indicator - Virtual Embodiment Questionnaire (VEQ) (French version) before and after personalization of the environment
Measured: At day 1
Indicator of tolerance: cyberkinetosis
SSQ - Simulator Sickness Questionnaire (French version) at the end of the experiment
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start10 Apr 2026
- Primary completion7 May 2026
- Study completion27 May 2026
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 Intervention StudyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Bouffard Vercelli - USSAP
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Responsible party
- Sponsor
- Investigators
- CHRISTINE AZEVEDO, PhD, Study director, Institut National de Recherche en Informatique et en AutomatiqueCHARLES FATTAL, MD, PhD, Principal investigator, Centre Bouffard Vercelli - USSAP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642804
- Sponsor's protocol ID
- 2025-A01444-45
- Other IDs
- 101099916
- Acronym
- I-GRIP
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moullet, E., Carpentier, J., Azevedo-Coste, C., & Bailly, F. (2024, November). I-GRIP, a Grasping Movement Intention Estimator for Intuitive Control of Assistive Devices. In 2024 IEEE-RAS 23rd International Conference on Humanoid Robots (Humanoids) (pp. 957-964).
Fonseca L, Tigra W, Navarro B, Guiraud D, Fattal C, Bo A, Fachin-Martins E, Leynaert V, Gelis A, Azevedo-Coste C. Assisted Grasping in Individuals with Tetraplegia: Improving Control through Residual Muscle Contraction and Movement. Sensors (Basel). 2019 Oct 18;19(20):4532. doi: 10.3390/s19204532.
PubMed 31635286Fonseca L, Bo A, Guiraud D, Navarro B, Gelis A, Azevedo-Coste C. Investigating Upper Limb Movement Classification on Users with Tetraplegia as a Possible Neuroprosthesis Interface. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:5053-5056. doi: 10.1109/EMBC.2018.8513418.
PubMed 30441476Tigra W, Dali M, William L, Fattal C, Gelis A, Divoux JL, Coulet B, Teissier J, Guiraud D, Azevedo Coste C. Selective neural electrical stimulation restores hand and forearm movements in individuals with complete tetraplegia. J Neuroeng Rehabil. 2020 May 19;17(1):66. doi: 10.1186/s12984-020-00676-4.
PubMed 32429963Fonseca L, Guiraud D, Hiairrassary A, Fattal C, Azevedo-Coste C. A Residual Movement Classification Based User Interface for Control of Assistive Devices by Persons With Complete Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2022;30:569-578. doi: 10.1109/TNSRE.2022.3156269. Epub 2022 Mar 21.
PubMed 35235517Coste CA, William L, Fonseca L, Hiairrassary A, Andreu D, Geffrier A, Teissier J, Fattal C, Guiraud D. Activating effective functional hand movements in individuals with complete tetraplegia through neural stimulation. Sci Rep. 2022 Oct 6;12(1):16189. doi: 10.1038/s41598-022-19906-x.
PubMed 36202865Fattal C, Teissier J, Geffrier A, Fonseca L, William L, Andreu D, Guiraud D, Azevedo-Coste C. Restoring Hand Functions in People with Tetraplegia through Multi-Contact, Fascicular, and Auto-Pilot Stimulation: A Proof-of-Concept Demonstration. J Neurotrauma. 2022 May;39(9-10):627-638. doi: 10.1089/neu.2021.0381. Epub 2022 Feb 2.
PubMed 35029125Azevedo Coste C, Guiho T, Ferreira F, Bailly F, Degeorge B, Geffrier A, Andreu D, Teissier J, Guiraud D, Fattal C. Restoring hand grasping for patients with a complete tetraplegia with selective epineural stimulation: a parsimonious thus relevant clinical approach. J Neuroeng Rehabil. 2026 Jan 14;23(1):111. doi: 10.1186/s12984-025-01857-9.
PubMed 41535942
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Virtual Reality Assessment of Control Interfaces for a Neuroprosthesis That Stimulates the Upper Limbs of Quadriplegic Individuals
- ClinicalTrials.gov ID
- NCT07642804
- Acronym / sponsor ID
- I-GRIP / 2025-A01444-45
- Conditions
- Intervention Study
- Keywords
- tetraplegia, upper limb, functional electrical stimulation, neuroprosthesis, virtual reality, control interfaces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Bouffard Vercelli - USSAPUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 11 Jun 2026 (actual)
- 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.
With a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices. The operating principle of the device we are interested in is to provide a set of predefined functional electrical stimulation (FES) configurations that activate specific hand movements (hand opening, palmar grasp, key grip, etc.), from which the user selects the one that is suitable for performing a task. The user control is usually based on commands from the contralateral limb (pressing a button, shoulder movement, or voluntary muscle contractions). These stereotypical and unintuitive commands hinder any possibility of bimanual tasks. Hands-free voice interfaces have been tested but have contextual limitations, particularly in terms of discretion or usability for certain activities such as eating. Furthermore, it is difficult to evaluate the performance of control interfaces and adjust them prior to the implantation of the stimulation neuroprosthesis. The aim of the I-GRIP project is to establish a methodology that is sufficiently realistic to enable people to envision their future use of a neuroprosthesis. Such a tool would also enable future candidates for implantation to better understand the device's potential. This approach would also make it possible to customize the technology prior to implantation (choice and adjustment of control interfaces, training, configuration of algorithms for analyzing movements evoked by stimulation, etc.).
Our main hypothesis is that two control interfaces (HMI1 and HMI2) will allow the user to control the completion of a grasping task (approach, grasp, hold) for each target object in the virtual environment simulating electrical stimulation of the forearm muscles.
Detailed description
Immersive, semi-immersive, or non-immersive VR has mainly been used for therapeutic rehabilitation purposes in patients with spinal cord injuries who have motor impairments in their upper limbs. A recent literature review in 2024 highlights a strong trend emerging from the analysis of all publications on the subject, namely an analytical gain in strength with no impact on manual dexterity, this gain being all the more significant the longer the training lasted (> 15 hours in total). In the field of functional electrical muscle stimulation, which is of interest to us here, Ajiboye et al. 2017 proposed post-implantation training of an upper limb (UL) stimulation neuroprosthesis in a quadriplegic patient under the control of a Brain Computer Interface (BCI) and compared object grasping performance in immersive VR and non-VR. Given that VR training was longer than non-VR training, movements were found to be smoother and more precise in VR. The uniqueness of this experiment lies in having established proof of concept around a subject's ability to control single and multi-coordinated movements with 80 to 100% accuracy using their thoughts, first using a virtual upper limb (UL) and then their own UL activated by FES to drink a cup of coffee and bring food to their mouth. It also highlighted the real value of immersive virtual reality in learning movements.
A recent publication of a clinical case study focused on the use of a Leap Motion optical hand tracking controller in a semi-immersive environment [Ahmed Al Nattah 2024]. Leap Motion, which is mainly used in kinematic assessments, is introduced in this publication for the purpose of rehabilitating the hand of an incomplete quadriplegic participant equipped with sensors and invited to perform exercises of increasing difficulty in custom-built video games offering both visual and auditory feedback. Beyond the promising therapeutic benefits observed in this single case study, this semi-immersive experience can be transposed into full immersion in applications such as the optimization and customization of neuroprosthesis control interfaces. VR is playing an increasingly decisive role in movement rehabilitation. It is part of the therapeutic arsenal that now aims to offer a fun, meaningful, and motivating approach to encourage the repetition of gestures and movements and, in fact, learning. However, its use as a tool for designing and evaluating the performance of assistive technology control interfaces has been little explored in studies, which justifies the approach adopted in this project.
With a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices. Such an environment would ultimately enable future users to prepare for the use of these devices and to project themselves into their use. This approach would also make it possible to customize the technology prior to implantation (choice and adjustment of control interfaces, training, configuration of algorithms for analyzing movements evoked by stimulation, etc.). In general, it is important to advance control interfaces to improve their ergonomics and usability. Here, we wish to show that virtual reality allows participants to realistically project themselves into an experience of using a neuroprosthesis that controls wrist extension and finger flexion/extension movements.
Participants will be equipped with a virtual reality headset that will project a virtual scene with various everyday objects and a representation of their hand. They will have to move their arm towards one of the objects in the scene, then trigger hand movements using one of the available control interfaces to grasp the object and manipulate it. Two methods of controlling the opening and closing movements of the fingers will be tested: HMI1: two physical buttons activated by pressing with the opposite hand to send commands, and HMI2 - shared control: the reaching movement of the arm towards the object is tracked using a video camera and automatically select the appropriate opening and gripping movements. HMI1 therefore requires a stereotypical action (pressing a button), while HMI2 allows automatic selection of grasping movements by observing the natural movements of approaching the object, which are observed by a camera and interpreted by an algorithm.
The experimental aspects of the study will be conducted over 2 sessions:
- (V1) Selection Visit: The selection visit will be conducted by the coordinating investigator, who will monitor the participant throughout the trial.
- (V2) Inclusion Visit: This visit will include: Clinical examination Collection of the signed consent form
- (V3 to V4) Experimental Visits: V3 (session 1): Taking measurements of the user to customize the models used for the virtual environment (2 hours max) V4 (session 2): Virtual immersion experiment (2 hours max)
- (V5) End-of-Study Visit: This final visit will consist of a clinical and psychological follow-up consultation to ensure the absence of any adverse effects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with complete tetraplegia AIS A or B, with a neurological level ≥ C7 | Experimental | Device: Virtual reality used as a simulation tool to evaluate and optimize the use of control interfaces |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Spinal cord injury defined by an AIS A, B or score (AIS A, B): complete or incomplete motor deficit below the lesion. This is a standard for describing spinalcord injuries that has been internationally agreed upon.
- Spinal cord injury at the neurological level > C7
- Age greater than or equal to 18 and less than or equal to 80 years
- A history of more than 3 months of neurological stability, with no changes in muscle testing.
- Participants capable of following instructions for testing and providing feedback on the use of the device.
Key exclusion criteria (7 listed)
- • Participant deprived of liberty (by judicial or administrative decision).
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 |
|---|---|---|
| Virtual reality used as a simulation tool to evaluate and optimize the use of control interfacesWith a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices. | Device | Patients with complete tetraplegia AIS A or B, with a neurological level ≥ C7 |
Primary outcome
Efficacy indicators
Time frame: At Day 1
Success rate (%) of the task (approach the object, grasp it with the dedicated grip, hold it for 5 seconds) over 10 repetitions for the each control modality. The expected success rate is at least 90% over all 10 repetitions for each control modality after a short learning phase.
5 secondary outcomes
Time workload indicators
Time frame: At day 1
Indicators of satisfaction, comfort, pleasure of use and subjective workload
Time frame: At day 1
Indicators of satisfaction, comfort, pleasure of use and subjective workload
Time frame: At day 1
Indicator of appropriation: quality of the embodiement in the VR environment Appropriation
Time frame: At day 1
Indicator of tolerance: cyberkinetosis
Time frame: At day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- BackgroundMoullet, E., Carpentier, J., Azevedo-Coste, C., & Bailly, F. (2024, November). I-GRIP, a Grasping Movement Intention Estimator for Intuitive Control of Assistive Devices. In 2024 IEEE-RAS 23rd International Conference on Humanoid Robots (Humanoids) (pp. 957-964).
- Background: PubMed 31635286Fonseca L, Tigra W, Navarro B, Guiraud D, Fattal C, Bo A, Fachin-Martins E, Leynaert V, Gelis A, Azevedo-Coste C. Assisted Grasping in Individuals with Tetraplegia: Improving Control through Residual Muscle Contraction and Movement. Sensors (Basel). 2019 Oct 18;19(20):4532. doi: 10.3390/s19204532.
- Background: PubMed 30441476Fonseca L, Bo A, Guiraud D, Navarro B, Gelis A, Azevedo-Coste C. Investigating Upper Limb Movement Classification on Users with Tetraplegia as a Possible Neuroprosthesis Interface. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:5053-5056. doi: 10.1109/EMBC.2018.8513418.
- Background: PubMed 32429963Tigra W, Dali M, William L, Fattal C, Gelis A, Divoux JL, Coulet B, Teissier J, Guiraud D, Azevedo Coste C. Selective neural electrical stimulation restores hand and forearm movements in individuals with complete tetraplegia. J Neuroeng Rehabil. 2020 May 19;17(1):66. doi: 10.1186/s12984-020-00676-4.
- Background: PubMed 35235517Fonseca L, Guiraud D, Hiairrassary A, Fattal C, Azevedo-Coste C. A Residual Movement Classification Based User Interface for Control of Assistive Devices by Persons With Complete Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2022;30:569-578. doi: 10.1109/TNSRE.2022.3156269. Epub 2022 Mar 21.
- Background: PubMed 36202865Coste CA, William L, Fonseca L, Hiairrassary A, Andreu D, Geffrier A, Teissier J, Fattal C, Guiraud D. Activating effective functional hand movements in individuals with complete tetraplegia through neural stimulation. Sci Rep. 2022 Oct 6;12(1):16189. doi: 10.1038/s41598-022-19906-x.
- Background: PubMed 35029125Fattal C, Teissier J, Geffrier A, Fonseca L, William L, Andreu D, Guiraud D, Azevedo-Coste C. Restoring Hand Functions in People with Tetraplegia through Multi-Contact, Fascicular, and Auto-Pilot Stimulation: A Proof-of-Concept Demonstration. J Neurotrauma. 2022 May;39(9-10):627-638. doi: 10.1089/neu.2021.0381. Epub 2022 Feb 2.
- Background: PubMed 41535942Azevedo Coste C, Guiho T, Ferreira F, Bailly F, Degeorge B, Geffrier A, Andreu D, Teissier J, Guiraud D, Fattal C. Restoring hand grasping for patients with a complete tetraplegia with selective epineural stimulation: a parsimonious thus relevant clinical approach. J Neuroeng Rehabil. 2026 Jan 14;23(1):111. doi: 10.1186/s12984-025-01857-9.
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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. This study is not recruiting at the moment.
CHRISTINE AZEVEDO, PhD study director
Institut National de Recherche en Informatique et en Automatique
CHARLES FATTAL, MD, PhD principal investigator
Centre Bouffard Vercelli - USSAP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Intervention Study, run by Centre Bouffard Vercelli - USSAP 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: finished, as of the sponsor's last update on 11 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy indicators (time frame: At Day 1). 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 NCT07642804, 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 11 Jun 2026.