TetraplegicsREGRASPNCT06620536
Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves
A study testing Electrical stimulation in people with Tetraplegics, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
The aim of the clinical investigation is to evaluate the feasibility, in terms of efficacy and safety, of a prosthetic system, the Regrasp 1 system, based on intraneural stimulation via TIME- 4H electrodes, as an aid device for restoring hand function in tetraplegic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tetraplegics
- What is being tested?
- Electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2024to Dec 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged between 18 and 70.
- Spinal cord injury at the C5-6 level, with complete motor paralysis (ASIA A or ASIA B).
- Chronic injury (\> 6 months), with stable clinical condition.
Who cannot join
- Systemic infections.
- Central and/or peripheral nervous system comorbidity.
- Reduced joint flexibility.
- Severe spasticity of the upper limb (mAS 3).
- Severe denervation of forearm and hand muscles (as demonstrated by electromyography and electroneurography analysis and intraoperative neural stimulation).
- Muscles not electrically excitable.
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- Presence of hyperalgesia or allodynia.
- Wearers of life support devices that could be adversely affected by electromagnetic interference, such as pacemakers, implanted cardioverter defibrillators, etc.
- Cognitive impairment.
- Active or history of psychiatric illnesses including major depression, bipolar disorder and personality disorders (borderline or antisocial personality disorder).
- Pregnancy.
- History of alcohol or substance abuse.
- Acquired brain injury with residual deficits.
- Participation in other clinical trials.
- Known allergies/hypersensitivity to TIME-4H electrode materials.
- Life expectancy of less than one year.
- Contraindications to general anaesthesia (patient refusal, severe aortic stenosis, significant pulmonary disease, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134
Salvatore De Masi, MD, 0557947807, demasis@aou-careggi.toscana.it
About this study
The aim of the clinical investigation is to evaluate the feasibility, in terms of efficacy and safety, of a prosthetic system, the Regrasp 1 system, based on intraneural stimulation via TIME- 4H electrodes, as an aid device for restoring hand function in tetraplegic patients.
Read the detailed description
The study involves implanting intraneural electrodes in the nerve used to open and close the hand.
Electrical stimulation will activate the forearm and hand muscles, and thus evoke movements such as opening and closing the fingers of the hand and wrist movements. Electrodes will be implanted temporarily and reversibly within the fascicles so that a more selective and therefore more effective stimulation can be determined. The electrodes will remain implanted for about 6 months.
During this period, the results of the external electrical stimulation will be analysed through experimental sessions that will take place at the Careggi University Hospital. At the end of the study, the electrodes will be removed by surgery under general anaesthesia.
- Conditions
- Tetraplegics
- Being tested
- Electrical stimulation
- Keywords
- electrodes, intraneural stimulation, hand, tetraplegia
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationDevice
Electrical stimulation of peripheral nerves for the recovery of hand function in tetraplegic patients of fundamental importance in improving quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Restoring hand function in patients with tetraplegia by intraneural stimulation of peripheral nerves | Experimental | Not described Receives: Device: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of REGRASP device, regarding muscle selectivity
The muscle selectivity index will be obtained by intraneural stimulation with a TIME-4H astimulator. Single stimulation pulses (1 Hz) will be applied from each active site of each implanted TIME-4H electrode. Simultaneously, electromyographic (EMG) signals of the flexor and extensor muscles of the forearm and hand, innervated by the median and radial nerves, respectively, will be recorded. For the EMG acquisitions we will use the CE-marked Sessantaquattro+ system. The peak-to-peak value of the compound muscle action potential (CMAP), evoked by each stimulation pulse, will be calculated and normalised with respect to the maximum value obtained for each muscle during the overall experimental session. These normalised levels of muscle activation will be used to define the relationship between current intensity and muscle recruitment for each active site and so to calculate an index of muscle selectivity.
Measured: from baseline to follow-up at month 6
efficacy of REGRASP device, regarding muscle functional selectivity
To assess functional selectivity, bursts of stimulation, with a duration of 0.5-1 sec, will be applied from each active site of each implanted TIME-4H. Evoked movements will be assessed using the Medical Research Council (MRC) scale. In addition, we will characterise evoked movements in terms of muscle activity patterns by recording the EMG activity of the muscles with the Sessantaquattro+ system, and in terms of kinematic patterns (amplitude and velocity) and generated force. The same experiments will then be performed by modulating the frequency of the stimulation bursts (in the range 10-100 Hz) while keeping the amplitude fixed at a value capable of generating functional movements. Thus, we will evaluate the possibility of gradually controlling the amplitude and force of the movement by adjusting the different stimulation parameters.
Measured: from baseline to follow-up at month 6
Muscle fatigue
To measure muscle fatigue, experiments will be conducted in which stimulation trains will be applied for approximately 20-30 seconds. At the same time, the EMG activity of the forearm and hand muscles and the grip force generated will be recorded. Some indices of muscle fatigue found in the literature will then be calculated, which measure, for example, the rate at which muscle strength decreases over time. The values obtained will be compared with those measured during voluntary contractions and with those induced by other stimulation modalities, such as FES with surface electrodes.
Measured: from baseline to follow-up at month 6
Functional recovery analysis
Restoration of hand function, in particular grasping movements and manipulation of objects, when the patient is assisted by the neuroprosthetic system. This will be assessed using four different tests with related score:
- the Grasp and Release test, awarded on the basis of the number of objects the patient is able to manipulate and the number of repetitions they are able to perform in a specific time interval;
- ADL test, used to evaluate the performance of the neuroprosthetic system when used during activities of daily living;
- GRASSP, a measure of clinical impairment that incorporates three vital domains of upper limb function: sensation, strength and grip;
- SCIM, a disability scale developed to specifically assess the ability of spinal cord injury patients to perform basic activities of daily living independently.
Measured: from baseline to follow-up at month 6
Secondary outcomes (1)
to evaluate possible plastic changes in the central nervous system induced by the use of the neuroprosthetic system.
Somatosensory cortical mapping of the paralysed hand will be performed using somatosensory evoked potentials (PESs). The median and ulnar nerves will be stimulated using bipolar surface electrodes at a frequency of 1 Hz. The amplitude of the response will be measured automatically by the BE Plus PRO system, as the difference between the peak potential and the signal baseline, for each electrode.
Measured: from baseline to follow-up at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegicsStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620536
- Sponsor's protocol ID
- REGRASP
- Acronym
- REGRASP
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves
- ClinicalTrials.gov ID
- NCT06620536
- Acronym / sponsor ID
- REGRASP / REGRASP
- Conditions
- Tetraplegics
- Keywords
- electrodes, intraneural stimulation, hand, tetraplegia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
The aim of the clinical investigation is to evaluate the feasibility, in terms of efficacy and safety, of a prosthetic system, the Regrasp 1 system, based on intraneural stimulation via TIME- 4H electrodes, as an aid device for restoring hand function in tetraplegic patients.
Detailed description
The study involves implanting intraneural electrodes in the nerve used to open and close the hand.
Electrical stimulation will activate the forearm and hand muscles, and thus evoke movements such as opening and closing the fingers of the hand and wrist movements. Electrodes will be implanted temporarily and reversibly within the fascicles so that a more selective and therefore more effective stimulation can be determined. The electrodes will remain implanted for about 6 months.
During this period, the results of the external electrical stimulation will be analysed through experimental sessions that will take place at the Careggi University Hospital. At the end of the study, the electrodes will be removed by surgery under general anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restoring hand function in patients with tetraplegia by intraneural stimulation of peripheral nerves | Experimental | Device: Electrical stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged between 18 and 70.
- Spinal cord injury at the C5-6 level, with complete motor paralysis (ASIA A or ASIA B).
- Chronic injury (\> 6 months), with stable clinical condition.
Key exclusion criteria (17 listed)
- Systemic infections.
- Central and/or peripheral nervous system comorbidity.
- Reduced joint flexibility.
- Severe spasticity of the upper limb (mAS 3).
- Severe denervation of forearm and hand muscles (as demonstrated by electromyography and electroneurography analysis and intraoperative neural stimulation).
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 |
|---|---|---|
| Electrical stimulationElectrical stimulation of peripheral nerves for the recovery of hand function in tetraplegic patients of fundamental importance in improving quality of life. | Device | Restoring hand function in patients with tetraplegia by intraneural stimulation of peripheral nerves |
Primary outcome
efficacy of REGRASP device, regarding muscle selectivity
Time frame: from baseline to follow-up at month 6
The muscle selectivity index will be obtained by intraneural stimulation with a TIME-4H astimulator. Single stimulation pulses (1 Hz) will be applied from each active site of each implanted TIME-4H electrode. Simultaneously, electromyographic (EMG) signals of the flexor and extensor muscles of the forearm and hand, innervated by the median and radial nerves, respectively, will be recorded. For the EMG acquisitions we will use the CE-marked Sessantaquattro+ system. The peak-to-peak value of the compound muscle action potential (CMAP), evoked by each stimulation pulse, will be calculated and normalised with respect to the maximum value obtained for each muscle during the overall experimental session. These normalised levels of muscle activation will be used to define the relationship between current intensity and muscle recruitment for each active site and so to calculate an index of muscle selectivity.
efficacy of REGRASP device, regarding muscle functional selectivity
Time frame: from baseline to follow-up at month 6
To assess functional selectivity, bursts of stimulation, with a duration of 0.5-1 sec, will be applied from each active site of each implanted TIME-4H. Evoked movements will be assessed using the Medical Research Council (MRC) scale. In addition, we will characterise evoked movements in terms of muscle activity patterns by recording the EMG activity of the muscles with the Sessantaquattro+ system, and in terms of kinematic patterns (amplitude and velocity) and generated force. The same experiments will then be performed by modulating the frequency of the stimulation bursts (in the range 10-100 Hz) while keeping the amplitude fixed at a value capable of generating functional movements. Thus, we will evaluate the possibility of gradually controlling the amplitude and force of the movement by adjusting the different stimulation parameters.
Muscle fatigue
Time frame: from baseline to follow-up at month 6
To measure muscle fatigue, experiments will be conducted in which stimulation trains will be applied for approximately 20-30 seconds. At the same time, the EMG activity of the forearm and hand muscles and the grip force generated will be recorded. Some indices of muscle fatigue found in the literature will then be calculated, which measure, for example, the rate at which muscle strength decreases over time. The values obtained will be compared with those measured during voluntary contractions and with those induced by other stimulation modalities, such as FES with surface electrodes.
Functional recovery analysis
Time frame: from baseline to follow-up at month 6
Restoration of hand function, in particular grasping movements and manipulation of objects, when the patient is assisted by the neuroprosthetic system. This will be assessed using four different tests with related score: * the Grasp and Release test, awarded on the basis of the number of objects the patient is able to manipulate and the number of repetitions they are able to perform in a specific time interval; * ADL test, used to evaluate the performance of the neuroprosthetic system when used during activities of daily living; * GRASSP, a measure of clinical impairment that incorporates three vital domains of upper limb function: sensation, strength and grip; * SCIM, a disability scale developed to specifically assess the ability of spinal cord injury patients to perform basic activities of daily living independently.
1 secondary outcome
to evaluate possible plastic changes in the central nervous system induced by the use of the neuroprosthetic system.
Time frame: from baseline to follow-up at month 6
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 1 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation in people with Tetraplegics, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 3 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: opening soon, as of the sponsor's last update on 1 Oct 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 Italy. 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 Sandra Pfanner, MD (0557948377, pfanners@aou-careggi.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of REGRASP device, regarding muscle selectivity (time frame: from baseline to follow-up at month 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2024.