A Bidirectional MyoKinetic Implanted Interface for Natural Control of Artificial Limbs (NCT06176482) | Clinical Trial Compass
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A Bidirectional MyoKinetic Implanted Interface for Natural Control of Artificial Limbs
Italy5 participantsStarted 2023-03-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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).
* 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 h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pick and Lift Test (PLT)
Timeframe: Six weeks.
2
Southampton Hand Assessment Procedure (SHAP)
Timeframe: Six weeks.
3
Minnesota Manual Dexterity Test (MMDT)
Timeframe: Six weeks.
4
Clothespin Relocation Test (CRT)
Timeframe: Six weeks.
5
Video recording in activities of the daily living (REC-ADL)
Timeframe: Six weeks.
6
Psychophysical test to understand the effect of vibration features on the elicited illusion of movement (VIB -FEATURES)