TetraplegiaSENSORSNCT07058506
Control Interfaces for Operating Assistive Devices
A study testing Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesis in people with Tetraplegia, run by Centre Bouffard Vercelli - USSAP at 1 site in France.
Trial summary
Neurinnov, in collaboration with the CBV USSAP center and the CAMIN INRIA team, has conducted clinical investigations using various control interfaces, including EMG, IMU, contact sensors, and voice commands, to operate a motor neuroprosthesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tetraplegia
- What is being tested?
- Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2024to 31 Dec 2025
- 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 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 C score (AIS A, B or C): complete or incomplete motor deficit below the lesion. This is a standard for describing spinal cord 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. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rehabilitation Center Bouffard-Vercelli USSAP
Perpignan, 66000
Charles FATTAL, MD, PhD, 33 (0)430441167, cfattal@ussap.fr
About this study
Official title: Evaluation of Non-invasive Control Interfaces for Operating Assistive Devices for Tetraplegic Individuals
Neurinnov, in collaboration with the CBV USSAP center and the CAMIN INRIA team, has conducted clinical investigations using various control interfaces, including EMG, IMU, contact sensors, and voice commands, to operate a motor neuroprosthesis. This neuroprosthesis is based on neural electrical stimulation, enabling the activation of multiples muscles via a single electrode. The clinical investigations have successfully demonstrated the feasibility of achieving grasping movements induced by neural electrical stimulation, which are controlled by the participant through external interfaces.
These external interfaces were based on existing technologies but were only suitable for research purposes due to their lack of portability. The current investigation aims to validate fully portable interfaces designed by Neurinnov, which are intended to be integral components of a future medical device that includes an implanted stimulator and its neural electrodes. The study's goal is to demonstrate that these interfaces can be used by participants with sufficient success rate (clinical performance) to support daily use.
Our main hypothesis is that the participants can effectively use at least two of the six control interfaces presented to them to detect their intention to perform a motor action within a software environment under constant conditions. These interfaces include voice commands, inertial measurement unit (IMU) sensors, surface electromyography (EMG) sensors, switch, joystick, and earswitch.
Read the detailed description
Various control interfaces (CIs) are used to capture user intent for operating assistive devices. In recent years, several methods have been developed to detect user intent for controlling invasive motor neuroprostheses for upper limbs. The Freehand System® utilized an external shoulder position sensor on the contralateral side to detect user intent and control hand grasp stimulation. In some studies, a switch was integrated with the sensor to turn the system on and off and to select the type of grasp (palmar or lateral). Brain-computer interface (BCI) systems based on electroencephalography (EEG) have also been employed. The Implantable Stimulator-Telemeter ('IST-10'), the second generation of the Freehand, had ten stimulation channels and was used with an implantable joint angle sensor. The third generation, the Implanted Stimulator Telemeter (IST-12), used myoelectric signals. However, no direct comparison has been made between these different modalities, nor has their relevance been determined.
Therefore, this study aims to evaluate the performance (efficacy: reliability and precision) of six non-invasive control interfaces. The efficacy criterion is defined by the ability to reliably and accurately control a motor action as illustrated by software on a screen. The six control interfaces are: (1) inertial measurement unit (IMU) sensors that record movements of the contralateral shoulder; (2) surface electromyography (EMG) sensors that capture voluntary muscle contractions of the contralateral limb; (3) a pressure sensor button (switch sensor); (4) a pressure sensor joystick (joystick sensor); (5) a voice recognition sensor (voice sensor) that incorporates a machine learning model capable of recognizing specific words spoken by the participant; and (6) an Ear-Switch® sensor that detects movements of a muscle inside the ear, the tensor tympani.
The study will be conducted over six 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
- Audio recordings of key words to personalize the speech recognition algorithms
- (V3 to V5) Experimental Visits:
- V3: Evaluation of all six control interfaces.
- V4: Detailed assessment of the two best-mastered control interfaces, both separately and in combination (bimodal use).
- V5: Intensity modulation visit, assessing the participant's ability to reliably and accurately reach target static and dynamic intensity levels (as shown on a screen) using two of the interfaces.
- (V6) 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
- Tetraplegia
- Being tested
- Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesis
- Keywords
- Tetraplegia, Non-invasive control interfaces, Sensors
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesisDevice
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with complete tetraplegia AIS A or B, with a neurological level ≥ C7 | Experimental | Not described Receives: Device: Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy indicators
Success rate: describes the ability of a control interface to execute requested functions under specified conditions Evaluation criterion: (Number of correctly recognized commands) / (Number of correctly recognized commands + Number of incorrectly recognized commands). Rate in percentage %
Measured: At Day 1
Secondary outcomes (12)
Time workload indicators
Latency between the user's actual intention and its detection, measured in seconds.
Measured: At Day 1
Indicator of feasibility: Ease of installation, calibration, and learning of each control interface (CI)
Evaluation criterion: Time tracked by the sensor control software, measured in minutes.
Measured: At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Indicator of feasibility: Ease of placing the control interface
Evaluation criterion: The number of times a third party (participant's caregiver or clinician) needed physical assistance and/or requested additional instructions to position the sensor.
Measured: At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Indicator of feasibility: Ease of learning to use the control interface
Evaluation criterion: The number of repetitions required for the participant to learn the interface.
At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Measured: At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Indicator of feasibility: User feedback concerning usability of the control interface
Evaluation criterion: System Usability Scale French Version (F-SUS) Score min: 10 and score max: 50
Measured: At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Indicator of tolerance : Pain experienced during and after using the interface
Evaluation criterion: visual analog scale (VAS) ranging from 0 to 10.
Measured: During the experimentation at Day 2 and 3
Indicator of tolerance : Adverse effects
Adverse effects encountered during and after using the interface.
Measured: During the experimentation at Day 2 and 3
Indicators of satisfaction, comfort, pleasure of use and subjective workload
User satisfaction with the control interface (CI) Evaluation criterion: Quebec User Evaluation of Satisfaction with Assistive Technology (French version = ESAT) . Score min : 12 and score max: 60
Measured: At Day 3
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: 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 3
Indicators of satisfaction, comfort, pleasure of use and subjective workload
User perception of subjective workload Evaluation criterion: 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 3
Indicators that a static and dynamic intensity value has been reached in a predetermined time (difference between target and initial value)
Static trial: successful target acquisition within the allotted time (acquisition time in seconds).
Measured: At Day 7
Indicators that a static and dynamic intensity value has been reached in a predetermined time (difference between target and initial value)
- Dynamic trial: the user-controlled value remains within a 10% margin of error relative to the reference value throughout the trial. (margin of error in percentage %)
Measured: At Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start18 Nov 2024
- Primary completion18 Nov 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TetraplegiaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Bouffard Vercelli - USSAP
- Sponsor type
- University, hospital or other
- Collaborators
- NEURINNOV, Institut National de Recherche en Informatique et en Automatique
- Responsible party
- Sponsor
- Investigators
- Charles FATTAL, MD, PhD, Principal investigator, Centre Bouffard Vercelli - USSAP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058506
- Sponsor's protocol ID
- 2024-A01014-43
- Other IDs
- 101099916
- Acronym
- SENSORS
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fattal 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 35029125Fonseca 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 35235517Tigra 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, 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 30441476Fonseca 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 31635286Coste 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 36202865
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-invasive Control Interfaces for Operating Assistive Devices for Tetraplegic Individuals
- ClinicalTrials.gov ID
- NCT07058506
- Acronym / sponsor ID
- SENSORS / 2024-A01014-43
- Conditions
- Tetraplegia
- Keywords
- Tetraplegia, Non-invasive control interfaces, Sensors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Bouffard Vercelli - USSAPUniversity, hospital or other
- Collaborators
- NEURINNOV, Institut National de Recherche en Informatique et en Automatique
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jul 2025 (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.
Neurinnov, in collaboration with the CBV USSAP center and the CAMIN INRIA team, has conducted clinical investigations using various control interfaces, including EMG, IMU, contact sensors, and voice commands, to operate a motor neuroprosthesis. This neuroprosthesis is based on neural electrical stimulation, enabling the activation of multiples muscles via a single electrode. The clinical investigations have successfully demonstrated the feasibility of achieving grasping movements induced by neural electrical stimulation, which are controlled by the participant through external interfaces.
These external interfaces were based on existing technologies but were only suitable for research purposes due to their lack of portability. The current investigation aims to validate fully portable interfaces designed by Neurinnov, which are intended to be integral components of a future medical device that includes an implanted stimulator and its neural electrodes. The study's goal is to demonstrate that these interfaces can be used by participants with sufficient success rate (clinical performance) to support daily use.
Our main hypothesis is that the participants can effectively use at least two of the six control interfaces presented to them to detect their intention to perform a motor action within a software environment under constant conditions. These interfaces include voice commands, inertial measurement unit (IMU) sensors, surface electromyography (EMG) sensors, switch, joystick, and earswitch.
Detailed description
Various control interfaces (CIs) are used to capture user intent for operating assistive devices. In recent years, several methods have been developed to detect user intent for controlling invasive motor neuroprostheses for upper limbs. The Freehand System® utilized an external shoulder position sensor on the contralateral side to detect user intent and control hand grasp stimulation. In some studies, a switch was integrated with the sensor to turn the system on and off and to select the type of grasp (palmar or lateral). Brain-computer interface (BCI) systems based on electroencephalography (EEG) have also been employed. The Implantable Stimulator-Telemeter ('IST-10'), the second generation of the Freehand, had ten stimulation channels and was used with an implantable joint angle sensor. The third generation, the Implanted Stimulator Telemeter (IST-12), used myoelectric signals. However, no direct comparison has been made between these different modalities, nor has their relevance been determined.
Therefore, this study aims to evaluate the performance (efficacy: reliability and precision) of six non-invasive control interfaces. The efficacy criterion is defined by the ability to reliably and accurately control a motor action as illustrated by software on a screen. The six control interfaces are: (1) inertial measurement unit (IMU) sensors that record movements of the contralateral shoulder; (2) surface electromyography (EMG) sensors that capture voluntary muscle contractions of the contralateral limb; (3) a pressure sensor button (switch sensor); (4) a pressure sensor joystick (joystick sensor); (5) a voice recognition sensor (voice sensor) that incorporates a machine learning model capable of recognizing specific words spoken by the participant; and (6) an Ear-Switch® sensor that detects movements of a muscle inside the ear, the tensor tympani.
The study will be conducted over six 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
- Audio recordings of key words to personalize the speech recognition algorithms
- (V3 to V5) Experimental Visits:
- V3: Evaluation of all six control interfaces.
- V4: Detailed assessment of the two best-mastered control interfaces, both separately and in combination (bimodal use).
- V5: Intensity modulation visit, assessing the participant's ability to reliably and accurately reach target static and dynamic intensity levels (as shown on a screen) using two of the interfaces.
- (V6) 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: Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesis |
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 C score (AIS A, B or C): complete or incomplete motor deficit below the lesion. This is a standard for describing spinal cord 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).
- Adult participants are under legal protection or unable to provide informed consent.
- Participation in another ongoing clinical trial.
- Unstable psychiatric condition.
- Severe cognitive impairment.
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 |
|---|---|---|
| Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesisNo intervention | 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: describes the ability of a control interface to execute requested functions under specified conditions Evaluation criterion: (Number of correctly recognized commands) / (Number of correctly recognized commands + Number of incorrectly recognized commands). Rate in percentage %
12 secondary outcomes
Time workload indicators
Time frame: At Day 1
Indicator of feasibility: Ease of installation, calibration, and learning of each control interface (CI)
Time frame: At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Indicator of feasibility: Ease of placing the control interface
Time frame: At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Indicator of feasibility: Ease of learning to use the control interface
Time frame: At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Indicator of feasibility: User feedback concerning usability of the control interface
Time frame: At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Indicator of tolerance : Pain experienced during and after using the interface
Time frame: During the experimentation at Day 2 and 3
Indicator of tolerance : Adverse effects
Time frame: During the experimentation at Day 2 and 3
Indicators of satisfaction, comfort, pleasure of use and subjective workload
Time frame: At Day 3
Indicators of satisfaction, comfort, pleasure of use and subjective workload
Time frame: At Day 3
Indicators of satisfaction, comfort, pleasure of use and subjective workload
Time frame: At Day 3
Indicators that a static and dynamic intensity value has been reached in a predetermined time (difference between target and initial value)
Time frame: At Day 7
Indicators that a static and dynamic intensity value has been reached in a predetermined time (difference between target and initial value)
Time frame: At Day 7
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 10 Jul 2025.
- 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 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 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 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 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 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.
- Individual participant dataSharing planned: No
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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.
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 testing Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesis in people with Tetraplegia, 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. 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 Charles FATTAL Charles FATTAL, MD, PhD (+33 430441100, cfattal@ussap.fr), or a site near the patient. 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 NCT07058506, which also lists 6 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 10 Jul 2025.