Upper Limb Amputation at the WristMYKYNCT06176482
A Bidirectional MyoKinetic Implanted Interface for Natural Control of Artificial Limbs
A study testing Magnetic markers implantation in people with Upper Limb Amputation at the Wrist, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
This is a European project that it will develop an innovative robotic hand prosthesis, whose movements can be controlled in a natural and intuitive way. The project will be financed with 1.5 million euros by the European Research Council (ERC), through the "ERC Starting Grant 2015" program, one of the most competitive… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Amputation at the Wrist
- What is being tested?
- Magnetic markers implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 31 Dec 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient is a uni- or bi-lateral trans-radial amputee.
- The patient had a traumatic amputation or a Congenital Hand Hypoplasia.
- The patient is 18 years or older, and younger than 70 years old.
- The amputation level guarantees to record muscle displacement and/or activity.
- The patient voluntarily accepts to receive the Myokinetic Interface.
- The patient voluntarily accepts to participate in all training and assessment sessions (follow-ups).
Who cannot join
- The patient is affected by peripheral vascular disease, neuropathies, or diabetes.
- The patient has current or prior dermatological conditions.
- The patient was diagnosed with a cognitive impairment, which prevents her/him from giving aware consent and following instructions.
- The patient has currently or had in the past psychological impairments (e.g., major personality disturbance, major depression, bipolar disorder).
- The patient has a history of or active substance abuse disorder.
- The patient has any concurrent disease or condition that might affect the treatment with the Myokinetic interface (e.g., neurological or musculoskeletal disorders).
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- The patient is pregnant or lactating.
- The patient is participating in another study that can affect the outcome of this study.
- The patient is a wearer of an electronic device for the monitoring/treatment of vital functions (e.g., pacemaker or defibrillator), whose use might be affected by the electromagnetic field.
- The patient has to perform a magnetic resonance examination during the period of implantation.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda ospedaliera Universitaria Pisana
Pisa, Pi, 56100
Lorenzo Andreani, +39050992029, lorenzo.andreani.unipi@gmail.com
About this study
Official title: Interventional Pilot Study on the Evaluation of the Functionality, the Safety, and the Reliability of an Implantable Bi-directional Myokinetic Interface for the Natural Control of Artificial Limbs
This is a European project that it will develop an innovative robotic hand prosthesis, whose movements can be controlled in a natural and intuitive way. The project will be financed with 1.5 million euros by the European Research Council (ERC), through the "ERC Starting Grant 2015" program, one of the most competitive globally.
According to current approaches (even the most technologically advanced or still under development) the control of the movements of the prosthetic hand occurs on the decoding of the electrical potentials, transmitted by the brain and captured by the peripheral neuromuscular system, through electrodes. The project has the ambition of wanting to overcome the limits of these techniques, through the development of an interface based on magnetic markers implantable in the muscles, capable of monitoring the elongation (lengthening) of the residual muscles, as happens naturally when performing a task motor (action), for example grabbing a bottle. With this information MYKI wants to control the movements of a robotic hand in a natural and intuitive way. In terms of potential, magnetic markers could also be used to provide a sensory feedback to the person wearing the robotic prosthesis, when it interacts with the environment, just as happens in the natural hand.
Read the detailed description
The 'MYKI- Studio Clinico' is a no-profit clinical study which aims at verifying the benefits and safety of an innovative upper limb interface, the Myokinetic interface, specifically conceived for patients with upper limb amputation. The study will verify whether the new interface, based on the use of implanted magnets, guarantees a natural and multi-degree of freedom control of robotic hands. Besides, the 'MYKI - Studio Clinico' will investigate if it is possible to convey physiologically appropriate proprioceptive information (i.e., movement and position information) of a missing finger or degrees of freedom through vibrations induced by implanted magnets. This idea is supported by the neuroscientific literature (Goodwin et al. 1972; Roll et al. 1989) and by studies conducted in the last years by the Sponsor's research group (see Clinical Investigator's Brochure ). Potential changes in the neurophysiological system will also be addressed. Finally, the controllability offered by the Myokinetic interface (i.e. the ability of the system to interpret the patient's voluntary motor commands, and to implement them on the robotic hand) will be experimentally compared with that offered by conventional surface electromyography (myoelectric prostheses).
The Myokinetic interface will produce a natural control and perception of robotic hands. The handbook "Manuale D'Uso" describes the instructions for the correct use of the device.
- Conditions
- Upper Limb Amputation at the Wrist
- Being tested
- Magnetic markers implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic markers implantationDevice
Surgical implantation of magnetic markers in the upper limb stump to allow the management of an external hand prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled and surgically treated | Experimental | Not described Receives: Device: Magnetic markers implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pick and Lift Test (PLT)
The PLT measures motor coordination, i.e., the ability to coordinate the grip force and the load force while lifting an object, as well as the reliability of the recorded control signal while transporting the object. While the subject is sitting on a chair with the intact arm parallel to the trunk, and the amputated limb extending anteriorly on a table, he/she is asked to lift a small object from the table with the prosthesis.
Measured: Six weeks.
Southampton Hand Assessment Procedure (SHAP)
The test consists of the sequential manipulation of 6 lightweight and 6 heavyweight abstract objects and 14 activities of daily living over a specific form-board. Lightweight objects should be manipulated first. The task involves pushing a button to start a timer, pick up and move the object from the rear slot to the front slot on the board, and complete the task by depressing the button on the timer again.
Measured: Six weeks.
Minnesota Manual Dexterity Test (MMDT)
The objective of the test is to measure the capacity for simple but rapid eye-hand-finger movement as well as arm-hand movement and gross motor skills. It is a standardized test focused on coordination, which involves the use of a specific testing board that is placed on a table in front of the subject. There are holes in the board forming a rectangular grid, and the subject has to position some disks inside the holes according to a specific pattern of movements previously explained and demonstrated by the operator. A stopwatch is used in order to time the test.
Measured: Six weeks.
Clothespin Relocation Test (CRT)
The objective is to evaluate the performance of a prosthetic user in a controlled environment and subsequently provide a measure of the expected functionality level of the user outside the laboratory/clinic. The user is instructed to allocate three clothespins between a horizontal rod and a vertical rod, and he/she is asked to fill out a post-test survey after five trials of the CRT.
Measured: Six weeks.
Video recording in activities of the daily living (REC-ADL)
The objective is to evaluate the ability of the subject to carry out Activities of Daily Living (ADL) using the prosthesis. As an example, the subject can be instructed to hold a rubber ball in his/her hand and to maintain a stable grasp while moving the arm and shoulder in space.
Measured: Six weeks.
Psychophysical test to understand the effect of vibration features on the elicited illusion of movement (VIB -FEATURES)
The objective of this study is to evaluate for each participant how vibration features (i.e., peak to peak amplitude, force, frequency, direction of the vibration) affect the participant perception and how we can improve the elicited illusion of movement in terms of vividness and range of motion. A psychophysical test will be conducted to determine the threshold of the parameters (frequency, amplitude, and vibration duration) in order to guarantee pleasant and effective sensory feedback.
Measured: Six weeks.
Embodiment test - Rubber Hand Test (RHT)
The test evaluates for each participant how vibrations induced illusion of movement affect the embodiment (i.e., ownership and agency sensations) of a robotic hand when visual feedback, tactile feedback, and motor commands are congruently or incongruently delivered. Measurements of questionnaires and proprioceptive shift will be acquired to evaluate the embodiment.
Measured: Six weeks.
Questionnaire for Phantom Limb (PLP)
The questionnaire evaluates the presence and the changes in PLP.
Measured: Six weeks.
Ultrasound Imaging (US)
Evaluation of the contraction capability of residual muscles, the presence of fibrotic tissue, the presence of muscle atrophy.
Measured: Six weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Mar 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Amputation at the WristStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Principal investigator, Lorenzo Andreani, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176482
- Sponsor's protocol ID
- 20084
- Acronym
- MYKY
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Pilot Study on the Evaluation of the Functionality, the Safety, and the Reliability of an Implantable Bi-directional Myokinetic Interface for the Natural Control of Artificial Limbs
- ClinicalTrials.gov ID
- NCT06176482
- Acronym / sponsor ID
- MYKY / 20084
- Conditions
- Upper Limb Amputation at the Wrist
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Dec 2023 (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.
This is a European project that it will develop an innovative robotic hand prosthesis, whose movements can be controlled in a natural and intuitive way. The project will be financed with 1.5 million euros by the European Research Council (ERC), through the "ERC Starting Grant 2015" program, one of the most competitive globally.
According to current approaches (even the most technologically advanced or still under development) the control of the movements of the prosthetic hand occurs on the decoding of the electrical potentials, transmitted by the brain and captured by the peripheral neuromuscular system, through electrodes. The project has the ambition of wanting to overcome the limits of these techniques, through the development of an interface based on magnetic markers implantable in the muscles, capable of monitoring the elongation (lengthening) of the residual muscles, as happens naturally when performing a task motor (action), for example grabbing a bottle. With this information MYKI wants to control the movements of a robotic hand in a natural and intuitive way. In terms of potential, magnetic markers could also be used to provide a sensory feedback to the person wearing the robotic prosthesis, when it interacts with the environment, just as happens in the natural hand.
Detailed description
The 'MYKI- Studio Clinico' is a no-profit clinical study which aims at verifying the benefits and safety of an innovative upper limb interface, the Myokinetic interface, specifically conceived for patients with upper limb amputation. The study will verify whether the new interface, based on the use of implanted magnets, guarantees a natural and multi-degree of freedom control of robotic hands. Besides, the 'MYKI - Studio Clinico' will investigate if it is possible to convey physiologically appropriate proprioceptive information (i.e., movement and position information) of a missing finger or degrees of freedom through vibrations induced by implanted magnets. This idea is supported by the neuroscientific literature (Goodwin et al. 1972; Roll et al. 1989) and by studies conducted in the last years by the Sponsor's research group (see Clinical Investigator's Brochure ). Potential changes in the neurophysiological system will also be addressed. Finally, the controllability offered by the Myokinetic interface (i.e. the ability of the system to interpret the patient's voluntary motor commands, and to implement them on the robotic hand) will be experimentally compared with that offered by conventional surface electromyography (myoelectric prostheses).
The Myokinetic interface will produce a natural control and perception of robotic hands. The handbook "Manuale D'Uso" describes the instructions for the correct use of the device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled and surgically treated | Experimental | Device: Magnetic markers implantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient is a uni- or bi-lateral trans-radial amputee.
- The patient had a traumatic amputation or a Congenital Hand Hypoplasia.
- The patient is 18 years or older, and younger than 70 years old.
- The amputation level guarantees to record muscle displacement and/or activity.
- The patient voluntarily accepts to receive the Myokinetic Interface.
Key exclusion criteria (10 listed)
- The patient is affected by peripheral vascular disease, neuropathies, or diabetes.
- The patient has current or prior dermatological conditions.
- The patient was diagnosed with a cognitive impairment, which prevents her/him from giving aware consent and following instructions.
- The patient has currently or had in the past psychological impairments (e.g., major personality disturbance, major depression, bipolar disorder).
- The patient has a history of or active substance abuse disorder.
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 |
|---|---|---|
| Magnetic markers implantationSurgical implantation of magnetic markers in the upper limb stump to allow the management of an external hand prosthesis | Device | Patients enrolled and surgically treated |
Primary outcome
Pick and Lift Test (PLT)
Time frame: Six weeks.
The PLT measures motor coordination, i.e., the ability to coordinate the grip force and the load force while lifting an object, as well as the reliability of the recorded control signal while transporting the object. While the subject is sitting on a chair with the intact arm parallel to the trunk, and the amputated limb extending anteriorly on a table, he/she is asked to lift a small object from the table with the prosthesis.
Southampton Hand Assessment Procedure (SHAP)
Time frame: Six weeks.
The test consists of the sequential manipulation of 6 lightweight and 6 heavyweight abstract objects and 14 activities of daily living over a specific form-board. Lightweight objects should be manipulated first. The task involves pushing a button to start a timer, pick up and move the object from the rear slot to the front slot on the board, and complete the task by depressing the button on the timer again.
Minnesota Manual Dexterity Test (MMDT)
Time frame: Six weeks.
The objective of the test is to measure the capacity for simple but rapid eye-hand-finger movement as well as arm-hand movement and gross motor skills. It is a standardized test focused on coordination, which involves the use of a specific testing board that is placed on a table in front of the subject. There are holes in the board forming a rectangular grid, and the subject has to position some disks inside the holes according to a specific pattern of movements previously explained and demonstrated by the operator. A stopwatch is used in order to time the test.
Clothespin Relocation Test (CRT)
Time frame: Six weeks.
The objective is to evaluate the performance of a prosthetic user in a controlled environment and subsequently provide a measure of the expected functionality level of the user outside the laboratory/clinic. The user is instructed to allocate three clothespins between a horizontal rod and a vertical rod, and he/she is asked to fill out a post-test survey after five trials of the CRT.
Video recording in activities of the daily living (REC-ADL)
Time frame: Six weeks.
The objective is to evaluate the ability of the subject to carry out Activities of Daily Living (ADL) using the prosthesis. As an example, the subject can be instructed to hold a rubber ball in his/her hand and to maintain a stable grasp while moving the arm and shoulder in space.
Psychophysical test to understand the effect of vibration features on the elicited illusion of movement (VIB -FEATURES)
Time frame: Six weeks.
The objective of this study is to evaluate for each participant how vibration features (i.e., peak to peak amplitude, force, frequency, direction of the vibration) affect the participant perception and how we can improve the elicited illusion of movement in terms of vividness and range of motion. A psychophysical test will be conducted to determine the threshold of the parameters (frequency, amplitude, and vibration duration) in order to guarantee pleasant and effective sensory feedback.
Embodiment test - Rubber Hand Test (RHT)
Time frame: Six weeks.
The test evaluates for each participant how vibrations induced illusion of movement affect the embodiment (i.e., ownership and agency sensations) of a robotic hand when visual feedback, tactile feedback, and motor commands are congruently or incongruently delivered. Measurements of questionnaires and proprioceptive shift will be acquired to evaluate the embodiment.
Questionnaire for Phantom Limb (PLP)
Time frame: Six weeks.
The questionnaire evaluates the presence and the changes in PLP.
Ultrasound Imaging (US)
Time frame: Six weeks.
Evaluation of the contraction capability of residual muscles, the presence of fibrotic tissue, the presence of muscle atrophy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic markers implantation in people with Upper Limb Amputation at the Wrist, run by Azienda Ospedaliero, Universitaria Pisana 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Andreani, MD PHD (+39050992029, lorenzo.andreani.unipi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pick and Lift Test (PLT) (time frame: Six weeks.). The study lists 9 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 19 Dec 2023.