QuadriplegiaAGILISNCT04306328
Neural Stimulation for Hand Grasp
A study testing Neurostimulation in people with Quadriplegia, run by Assistance Publique - Hôpitaux de Paris 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 and radial nerves. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quadriplegia
- What is being tested?
- Neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2020to 11 Dec 2020
- 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
- 18 years old ≤ age ≤ 65 years old,
- 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)
- neurological stability (no change in muscle testing) > 6 months,
- post-injury duration > 6 months
- 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 17Show fewer
- unstable cardiovascular pathology (coronary heart disease, major hypertension, heart failure, etc.).
- infectious pathology under treatment at the inclusion visit
- wearing a pacemaker.
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Service MPR: USSAP Centre Bouffard-Vercelli, Pôle Santé du
Perpignan, 66962
About this study
Official title: Functional Evaluation of the Recovery of Prehension in Quadriplegics 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 and 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 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, 2 electrodes will be implanted above the elbow on the median and 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 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 two cuff electrodes with percutaneous connection on the arm of quadriplegic people. 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.
- Conditions
- Quadriplegia
- Being tested
- Neurostimulation
- Keywords
- Percutaneous Electrical Nerve Stimulation
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulationDevice
Implantation of 2 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 | Not described Receives: Device: Neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selectivity index of the configurations which allow an individualized recruitment of the different muscles at D+29
Selectivity index of the configurations (active contacts of the electrode and stimulation parameters) which allow an individualized recruitment of the different muscles at D+29 based on the combination of the increase of the Root Mean Square (RMS) value of the Electromyography (EMG) and variation of 10% of the maximum distance covered by the considered segment compared with the rest position.
Measured: End of the protocole (day 29)
Secondary outcomes (8)
Motor Capacities Scale (MCS)
The Motor Capacity Scale (MCS) which studies the Key Grip and Grasp sockets in their 3 facets (catching, holding and letting go). MCS should be above 27.
Measured: Day 29
Test n°1 of the 400 Points assessment
functional relevance of neural implantation via the production of 4 movements considered useful: an opening of the 5 fingers, a digito-palmar grip with thumb, a digito-palmar grip without thumb and an end-to-side thumb grip Test No. 1 of the 400 POINTS balance sheet, which brings together the study of 12 hand functions. POINTS score should be above 60.
Measured: Day 29
The rate in % of total tests of grasping objects.
Testing of two methods of autonomous control of the device by the patient. The successful rate in % of total tests of grasping objects. The success rate should be above 80%.
Measured: Day 29
Optimal stimulation strategies obtained for a synergistic functional control
For each movement, the minimum stimulation intensity to produce the movement will be noted. In mA this intensity should be as low as possible. A value above 1.5 mA of failure to obtain the desired movement will be considered as a failed outcome.
Measured: Day 29
The impedance of the electrode contacts.
Assessment of the evolution of the quality of the stimulation over time (stability of the settings and of the tissue / electrode interface). A Impedance of the electrode contacts to assess the state of the contact between the electrode poles and the nerve tissue.
The state of contact between the electrode poles and the nervous tissue will be evaluated by measuring the impedance of the electrode contacts. This impedance expressed in k ohms, should not be higher than 5. Above this threshold the contact will be considered to be non-functional.
For each movement, the minimum stimulation intensity (in mA) to initiate the movement should stay below 1.5 mA.
Measured: Day 29
Local skin tolerance
Local skin tolerance assessed by the number of patients with dermatological lesions at the implantation site, of allergic and/or infectious type during the month following implantation. The answer provided daily will be binary yes / no.
Measured: Day 29
Local algological tolerance (1)
Local algological tolerance assessed by number of patients with at least one pain at the implant site, qualified as neuropathic or nociceptive and quantified as > or = 3/10 using a digital analog scale from 0 to 10, during the month following implantation.
Measured: Day 29
Local algological tolerance (2)
Local algological tolerance assessed by average intensity of daily pain
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start15 Oct 2020
- Primary completion24 Nov 2020
- Study completion11 Dec 2020
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 QuadriplegiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, NEURINNOV, Centre Bouffard Vercelli - USSAP
- Responsible party
- Sponsor
- Investigators
- Charles FATTAL, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306328
- Sponsor's protocol ID
- APHP190280
- Acronym
- AGILIS
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azevedo 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 41535942Coste 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evaluation of the Recovery of Prehension in Quadriplegics by Implanted Neural Stimulation
- ClinicalTrials.gov ID
- NCT04306328
- Acronym / sponsor ID
- AGILIS / APHP190280
- Conditions
- Quadriplegia
- Keywords
- Percutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, NEURINNOV, Centre Bouffard Vercelli - USSAP
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 12 Mar 2020 (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 and 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 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, 2 electrodes will be implanted above the elbow on the median and 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 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 two cuff electrodes with percutaneous connection on the arm of quadriplegic people. 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.
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 | Device: Neurostimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent signed
- Patient affiliated to a social security (state medical aid excepted).
- Neurological level ≥ C7
- 18 years old ≤ age ≤ 65 years old,
- 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)
Key exclusion criteria (17 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 2 multicontact cuff electrodes in the upper limb of patients with tetraplegia and control of the stimulation by contralateral shoulder movements | Device | Neurostimulation |
Primary outcome
Selectivity index of the configurations which allow an individualized recruitment of the different muscles at D+29
Time frame: End of the protocole (day 29)
Selectivity index of the configurations (active contacts of the electrode and stimulation parameters) which allow an individualized recruitment of the different muscles at D+29 based on the combination of the increase of the Root Mean Square (RMS) value of the Electromyography (EMG) and variation of 10% of the maximum distance covered by the considered segment compared with the rest position.
8 secondary outcomes
Motor Capacities Scale (MCS)
Time frame: Day 29
Test n°1 of the 400 Points assessment
Time frame: Day 29
The rate in % of total tests of grasping objects.
Time frame: Day 29
Optimal stimulation strategies obtained for a synergistic functional control
Time frame: Day 29
The impedance of the electrode contacts.
Time frame: Day 29
Local skin tolerance
Time frame: Day 29
Local algological tolerance (1)
Time frame: Day 29
Local algological tolerance (2)
Time frame: Day 29
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 25 Feb 2021.
- 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.
- Derived from this study: 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. This study is not recruiting at the moment.
Charles FATTAL, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Quadriplegia, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 17 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 25 Feb 2021. 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?
Selectivity index of the configurations which allow an individualized recruitment of the different muscles at D+29 (time frame: End of the protocole (day 29)). 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 NCT04306328, 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 25 Feb 2021.