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The NEBIAS ("NEurocontrolled BIdirectional Artificial upper limb and hand prosthesiS") proposal aims at developing and clinically evaluating (in selected amputees) a neuro-controlled upper limb prosthesis intuitively controlled and felt by the amputee as the natural one. This will be possible by means of a novel neural interface able to provide a stable and very selective connection with the nervous system. This goal will be achieved by combining microtechnology and material science and will allow, on one side, recording of the motor-related signals governing the actions of the amputated hand/arm for the motion control of a mechanical prosthesis, and on the other providing sensory feedback from tactile and kinesthetic sensors through neuromorphic stimulation of the adequate afferent pathway within the residual limb. The NEBIAS proposal is also aimed at finding out the 'language' intrinsically linking central nervous system with peripheral nerve signals in order to govern simple and complex hand/fingers movements. To reach this goal, a variety of techniques exploring brain and nerve functions will be assembled and integrated; this includes the analysis of electromagnetic brain and nerve signals, as well as of movement-related changes in brain's blood flow/metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Hand | Experimental | The two patient enrolled will perform the task requiring the use of the robotic hand. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Hand | Device | The patients will use the robotic hand for a period of one year that will be divided in 3 different phases. The first phase is the intensive phase where the patient will use the robotic hand from Monday to Friday all days. This phase will last 6 weeks. The second phase is the semi-intensive where the patient will use the robotic hand only two days per week. This phase will last 6 weeks. The third phase is the monitoring where the patient will use the robotic hand only one day per week until the end of the trial. During this phases the patient will perform different task requiring the use of the robotic hand. |
| Measure | Description | Time Frame |
|---|---|---|
| performance of the robotic hand | Different level of pressure (percentage of success); | 1 year |
| performance of the robotic hand | Virtual egg test (percentage of success); | 1 year |
| performance of the robotic hand | Pick and Lift (percentage of success); | 1 year |
| performance of the robotic hand | Texture recognition (percentage of success); | 1 year |
| performance of the robotic hand | Shape recognition (percentage of success); | 1 year |
| performance of the robotic hand | Compliance recognition (percentage of success) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical map changes | Primary motor area (change of dimension and shape); | 1 year |
| Cortical map changes | Primary somatosensory area (change of dimension and shape); |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Maria M Rossini, Professor | Contact | 00390635504435 | paolomaria.rossini@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| paolo m rossini, professor | Catholic University of the Sacred Heart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Agostino Gemelli | Recruiting | Rome | Lazio | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33725672 | Derived | Cracchiolo M, Panarese A, Valle G, Strauss I, Granata G, Iorio RD, Stieglitz T, Rossini PM, Mazzoni A, Micera S. Computational approaches to decode grasping force and velocity level in upper-limb amputee from intraneural peripheral signals. J Neural Eng. 2021 Apr 6;18(5). doi: 10.1088/1741-2552/abef3a. | |
| 32318562 | Derived |
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|
| 1 year |
| Valle G, D'Anna E, Strauss I, Clemente F, Granata G, Di Iorio R, Controzzi M, Stieglitz T, Rossini PM, Petrini FM, Micera S. Hand Control With Invasive Feedback Is Not Impaired by Increased Cognitive Load. Front Bioeng Biotechnol. 2020 Apr 3;8:287. doi: 10.3389/fbioe.2020.00287. eCollection 2020. |