TetraplegiaAGILISNCT05555914
Neural Stimulation for Hand Grasp in People With Tetraplegia
A study testing Neurostimulation in people with Tetraplegia, run by Centre Bouffard Vercelli - USSAP at 1 site in France.
Trial summary
A selective neural stimulation as the investigators propose allows to stimulate several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, 2 electrodes will be implanted above the elbow on the median, the ulnar and the radial nerves. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tetraplegia
- What is being tested?
- Neurostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to 31 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed
- Patient affiliated to a social security (state medical aid excepted).
- Neurological level ≥ C7 4.18 years old ≤ age ≤ 65 years old,
- 5.complete traumatic injury: defined by an A or B score on the AIS scale. (AIS A or - complete motor deficit under injury. This is an internationally agreed standard for describing spinal cord injury) 6.neurological stability (no change in muscle testing) > 6 months, 7.post-injury duration > 6 months 8.patients without active muscle resources for conventional tendon transfer surgery on the forearm and hand
Who cannot join
- patient deprived of liberty (by judicial or administrative decision).
- adult patient who is subject to a legal protection measure or unable to express consent
- participation in another ongoing clinical trial
- pregnant or breastfeeding women or women of childbearing age without effective contraception
- spasticity and contractures in flexion or extension of the upper limbs of a destabilizing nature.
- unstable epilepsy with a notion of a epileptic seizure that occurred within the previous 12 months.
Show all 18Show fewer
- unstable cardiovascular pathology (coronary heart disease, major hypertension, heart failure, etc.).
- infectious pathology under treatment at the inclusion visit
- wearing a pacemaker or a spinal cord stimulator implant
- dermatological problems contraindicating the application of surface electrodes.
- body weight >100 kg
- psychiatric condition and/or history contraindicating participation in research
- any contraindications to anesthesia and/or surgery
- hypersensitivity to low molecular weight heparin (LMWH) or to any of the excipients of the specialty used
- history of immune-mediated heparin-induced thrombocytopenia (HIT) within the last 100 days or presence of circulating antibodies
- clinically significant active bleeding or a condition associated with a high risk of bleeding
- electrical mapping identified as negative during the inclusion visit, i.e. with muscles revealing a rating < 4 MRC for at least one of the extensors (ECRL, ECRB, EDC, EPL) or one of the flexors (FPL, FDS, FDP).
- bone fracture on the upper limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Evaluation of the Recovery of Prehension in Persons With Tetraplegia by Implanted Neural Stimulation
A selective neural stimulation as the investigators propose allows to stimulate several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, 2 electrodes will be implanted above the elbow on the median, the ulnar and the radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk through minimally invasive surgery.
Our main hypothesis is that multipolar neural electrical stimulation of the median and the ulnar nerve (flexion) and the radial nerve (extension) allows:
- on the one hand, a selective, individualized motor activation (muscle by muscle)
- on the other hand, a synergistic motor activation (association of several muscles) for the purpose of production of functional movements.
Read the detailed description
Electrical stimulation of the muscles has been used for decades in rehabilitation units specializing in the treatment of spinal cord injuries. It has been shown to be effective in building muscle and preventing muscle atrophy following spinal cord injury (SCI) or stroke. It can also be used to reduce spasticity and above all to promote functionally useful motor control. It is then a Functional Electric Stimulation (FES). In the quadriplegic person marked by a severe motor deficiency of the upper limbs, FES is today the only technique allowing to restore a functional gripping movements in the case where the active muscular resources below the elbows are missing or too weak to allow tendon transfer surgery.
Like "Freehand", all the devices using FES directly stimulate the muscles (surface, intramuscular or epimysial electrodes) and therefore require a high number of internal components with a theoretical risk of infection and greater rejection. since each muscle must be activated via an electrode (up to 12 in the case of "FreeHand"). The investigators propose instead selective neural stimulation as it allows stimulating several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, three electrodes will be implanted above the elbow on the median, the ulnar and the radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk thanks to minimally invasive surgery. The procedure consisted of placing a multi-contact cuff electrode around the radial, ulnar or median nerves and observing the effects of electrical neural stimulation in terms of muscle selectivity, force produced and movement induced. In a previous study, the investigators already proved through acute intra operative testing (under Ethics Committee approval, #NCT03721861) that:
No failure of the electrodes or of the stimulator was noted. For all of the 8 subjects, it was possible to selectively stimulate muscle groups to obtain the opening of the thumb and fingers, or the flexion of the thumb, fingers and obtaining possibly functional grip like the forceps with opposition of the thumb or palmar grip.
A second feasibility study (Ethics committee registration #2016-A00711-50) with 17 quadriplegic patients assessed the subject's ability to use voluntary contractions of sus lesional muscles (EMG recordings in 8 subjects) or voluntary movements of shoulders (inertial recordings in 9 subjects) to control the movements of a robotic hand or the triggering of an electrical surface stimulation of the muscles of the forearm. All of the patients managed to master the proposed interface after a short familiarization period.
On the basis of the results of these two studies, the investigator wish to take an additional step in the development of a gripping assistance device for patients with spinal cord injury by proposing the implantation of three cuff electrodes with percutaneous connection on the arm of people with tetraplegia. The electrodes will be kept in place for a period of 1 month before being definitively explanted. An implanted cable will connect the electrodes to an external connector. A preliminary study based on the implantation of only 2 electrodes (on the median and the radial nerve) was conducted in 2020 in 2 patients.vNeither of the 2 participants showed general and local comorbidity. Acceptability was optimal. None of the stimulation configurations generated contradictory movements. The success rate in task execution by the electro-stimulated hand exceeded the target of 50% (54% and 51% for patient 1 and 2 respectively). The compliance rate of the control orders in both patients was > 90% using motion IMU-based detection and 100% using EMG-based detection in patient 1. These results support the relevance of neural stimulation of the tetraplegic upper limb with a more selective approach, using multi-contact epineural electrodes with 9 and 6 contact points for the median and radial nerve respectively.
- Conditions
- Tetraplegia
- Being tested
- Neurostimulation
- Keywords
- Tetraplegia, Neural stimulation
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulationOther
Implantation of 3 multicontact cuff electrodes in the upper limb of patients with tetraplegia and control of the stimulation by contralateral shoulder movements
| Study group | Role | What they receive |
|---|---|---|
| Neurostimulation | Experimental | Implantation of 3 multicontact cuff electrodes in the upper limb of patients with tetraplegia Receives: Other: Neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome: Number of successful trials (task completed) out of 5 trials with 5 preselected objects.
The objective is to show that neural electrical stimulation allows the user to master the completion of each of pre-selected gripping tasks.
The evaluation criteria is the number of successful trials (task completed) out of 5 trials with 5 preselected objects. For each object, a successful gripping task is a task completed in a duration <180 sec.
Measured: Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29
Secondary outcomes (7)
Functional outcome
Evaluation of the patient's ability to perform functional takes (gripping, moving, letting go) of 5 objects chosen by the user, by means of multi-contact neural stimulation of the median, ulnar and radial nerves.
Evaluation criterion: Canadian Occupational Performance Measure (COPM)
Measured: Following surgery from Day12: Day12, Day15, Day17, Day22, Day26 and Day29
Strength
Measurements at the beginning and end of each session, in order to follow the exhaustion of the force produced over the course of the tests.
The grip force is measured for 5 seconds with two gauges for each of the 2 takes three times in a row before any evaluation of the gripping tasks and 3 times in a row at the end of the 5 objects X 5 gripping tests. The average of the 3 measures is retained Evaluation criterion: Grip strength test and pinch grip test (dynamometer)
Measured: Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29
Fatigue
To measure a person's perception of his efforts and exertion and fatigue during each trial.
Evaluation criterion: Borg test
Measured: Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29
Self perception and psychological well being
To measure a person's perception of his well being. Evaluation criterion: The 5-item World Health Organization Well-Being Index (WHO-5)
Measured: Baseline prior to surgery and following surgery: Day8, Day15, Day22, Day29
System Usability Scale
To measure the potential usability of FES and the satisfaction provided by the use of the implanted electrical stimulation Evaluation criterion: The System Usability Scale (SUS).
SUS scores have a range of 0 to 100. Scores for individual items are not meaningful on their own.The higher the score, the higher the perceived usability.
Measured: Following surgery : Day8 and Day29
Local tolerance
From the skin point of view, to look for an allergic and / or infectious dermatological lesion at the implantation site. The answer provided daily will be binary yes / no.
Measured: Following surgery: daily from Day0 to Day29
Pain assessment using the Visual Analog Scale (VAS)
From an algological point of view, assessment of the emergence or worsening of pain (score above 3/10 on the Analog Pain Scale) or a mean score above 3/10.
Measured: Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start10 Oct 2022
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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, NEURINNOV
- Responsible party
- Sponsor
- Investigators
- Charles FATTAL, MD, PhD, Principal investigator, Centre Bouffard Vercelli - USSAP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555914
- Sponsor's protocol ID
- 2022-A00205-38
- Acronym
- AGILIS
- Status last verified
- Oct 2022
- First submitted
- 29 Aug 2022
- Last updated
- 29 Jan 2024
- 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 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evaluation of the Recovery of Prehension in Persons With Tetraplegia by Implanted Neural Stimulation
- ClinicalTrials.gov ID
- NCT05555914
- Acronym / sponsor ID
- AGILIS / 2022-A00205-38
- Conditions
- Tetraplegia
- Keywords
- Tetraplegia, Neural stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Bouffard Vercelli - USSAPUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, NEURINNOV
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Sep 2022 (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.
A selective neural stimulation as the investigators propose allows to stimulate several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, 2 electrodes will be implanted above the elbow on the median, the ulnar and the radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk through minimally invasive surgery.
Our main hypothesis is that multipolar neural electrical stimulation of the median and the ulnar nerve (flexion) and the radial nerve (extension) allows:
- on the one hand, a selective, individualized motor activation (muscle by muscle)
- on the other hand, a synergistic motor activation (association of several muscles) for the purpose of production of functional movements.
Detailed description
Electrical stimulation of the muscles has been used for decades in rehabilitation units specializing in the treatment of spinal cord injuries. It has been shown to be effective in building muscle and preventing muscle atrophy following spinal cord injury (SCI) or stroke. It can also be used to reduce spasticity and above all to promote functionally useful motor control. It is then a Functional Electric Stimulation (FES). In the quadriplegic person marked by a severe motor deficiency of the upper limbs, FES is today the only technique allowing to restore a functional gripping movements in the case where the active muscular resources below the elbows are missing or too weak to allow tendon transfer surgery.
Like "Freehand", all the devices using FES directly stimulate the muscles (surface, intramuscular or epimysial electrodes) and therefore require a high number of internal components with a theoretical risk of infection and greater rejection. since each muscle must be activated via an electrode (up to 12 in the case of "FreeHand"). The investigators propose instead selective neural stimulation as it allows stimulating several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, three electrodes will be implanted above the elbow on the median, the ulnar and the radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk thanks to minimally invasive surgery. The procedure consisted of placing a multi-contact cuff electrode around the radial, ulnar or median nerves and observing the effects of electrical neural stimulation in terms of muscle selectivity, force produced and movement induced. In a previous study, the investigators already proved through acute intra operative testing (under Ethics Committee approval, #NCT03721861) that:
No failure of the electrodes or of the stimulator was noted. For all of the 8 subjects, it was possible to selectively stimulate muscle groups to obtain the opening of the thumb and fingers, or the flexion of the thumb, fingers and obtaining possibly functional grip like the forceps with opposition of the thumb or palmar grip.
A second feasibility study (Ethics committee registration #2016-A00711-50) with 17 quadriplegic patients assessed the subject's ability to use voluntary contractions of sus lesional muscles (EMG recordings in 8 subjects) or voluntary movements of shoulders (inertial recordings in 9 subjects) to control the movements of a robotic hand or the triggering of an electrical surface stimulation of the muscles of the forearm. All of the patients managed to master the proposed interface after a short familiarization period.
On the basis of the results of these two studies, the investigator wish to take an additional step in the development of a gripping assistance device for patients with spinal cord injury by proposing the implantation of three cuff electrodes with percutaneous connection on the arm of people with tetraplegia. The electrodes will be kept in place for a period of 1 month before being definitively explanted. An implanted cable will connect the electrodes to an external connector. A preliminary study based on the implantation of only 2 electrodes (on the median and the radial nerve) was conducted in 2020 in 2 patients.vNeither of the 2 participants showed general and local comorbidity. Acceptability was optimal. None of the stimulation configurations generated contradictory movements. The success rate in task execution by the electro-stimulated hand exceeded the target of 50% (54% and 51% for patient 1 and 2 respectively). The compliance rate of the control orders in both patients was > 90% using motion IMU-based detection and 100% using EMG-based detection in patient 1. These results support the relevance of neural stimulation of the tetraplegic upper limb with a more selective approach, using multi-contact epineural electrodes with 9 and 6 contact points for the median and radial nerve respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurostimulation | Experimental | Other: NeurostimulationImplantation of 3 multicontact cuff electrodes in the upper limb of patients with tetraplegia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent signed
- Patient affiliated to a social security (state medical aid excepted).
- Neurological level ≥ C7 4.18 years old ≤ age ≤ 65 years old,
- 5.complete traumatic injury: defined by an A or B score on the AIS scale. (AIS A or - complete motor deficit under injury. This is an internationally agreed standard for describing spinal cord injury) 6.neurological stability (no change in muscle testing) > 6 months, 7.post-injury duration > 6 months 8.patients without active muscle resources for conventional tendon transfer surgery on the forearm and hand
Key exclusion criteria (18 listed)
- patient deprived of liberty (by judicial or administrative decision).
- adult patient who is subject to a legal protection measure or unable to express consent
- participation in another ongoing clinical trial
- pregnant or breastfeeding women or women of childbearing age without effective contraception
- spasticity and contractures in flexion or extension of the upper limbs of a destabilizing nature.
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 |
|---|---|---|
| NeurostimulationImplantation of 3 multicontact cuff electrodes in the upper limb of patients with tetraplegia and control of the stimulation by contralateral shoulder movements | Other | Neurostimulation |
Primary outcome
Functional outcome: Number of successful trials (task completed) out of 5 trials with 5 preselected objects.
Time frame: Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29
The objective is to show that neural electrical stimulation allows the user to master the completion of each of pre-selected gripping tasks. The evaluation criteria is the number of successful trials (task completed) out of 5 trials with 5 preselected objects. For each object, a successful gripping task is a task completed in a duration <180 sec.
7 secondary outcomes
Functional outcome
Time frame: Following surgery from Day12: Day12, Day15, Day17, Day22, Day26 and Day29
Strength
Time frame: Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29
Fatigue
Time frame: Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29
Self perception and psychological well being
Time frame: Baseline prior to surgery and following surgery: Day8, Day15, Day22, Day29
System Usability Scale
Time frame: Following surgery : Day8 and Day29
Local tolerance
Time frame: Following surgery: daily from Day0 to Day29
Pain assessment using the Visual Analog Scale (VAS)
Time frame: Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29
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 29 Jan 2024.
- Results publication: 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.
- Derived from this study: 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.
- 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. This study is not recruiting at the moment.
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 Neurostimulation 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 4 inclusion and 18 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 29 Jan 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?
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?
Functional outcome: Number of successful trials (task completed) out of 5 trials with 5 preselected objects. (time frame: Baseline prior to surgery and following surgery: Day5, Day6, Day8, Day12, Day15, Day17, Day22, Day26 and Day29). 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 NCT05555914, which also lists 2 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 29 Jan 2024.