Clinical trial NCT06176482: A Bidirectional MyoKinetic Implanted Interface for Natural Control of Artificial Limbs
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Limb Amputation at the Wrist
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
Collaborators: name: Scuola Superiore Sant'Anna di Pisa
First posted: 2023-12-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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.

Eligibility criteria: 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 has to perform a magnetic resonance examination during the period of implantation.

Primary outcomes:
measure: Pick and Lift Test (PLT)
timeFrame: Six weeks.
measure: Southampton Hand Assessment Procedure (SHAP)
timeFrame: Six weeks.
measure: Minnesota Manual Dexterity Test (MMDT)
timeFrame: Six weeks.
measure: Clothespin Relocation Test (CRT)
timeFrame: Six weeks.
measure: Video recording in activities of the daily living (REC-ADL)
timeFrame: Six weeks.
measure: Psychophysical test to understand the effect of vibration features on the elicited illusion of movement (VIB -FEATURES)
timeFrame: Six weeks.
measure: Embodiment test - Rubber Hand Test (RHT)
timeFrame: Six weeks.
measure: Questionnaire for Phantom Limb (PLP)
timeFrame: Six weeks.
measure: Ultrasound Imaging (US)
timeFrame: Six weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda ospedaliera Universitaria Pisana
state: Pi
Study officials:
References: