NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS

Study Overview
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Brief Summary
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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.

Official Title
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NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS

Conditions
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Sensorized Hand Prosthesis

Intervention / Treatment
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* Device: Robotic Hand


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult man or woman >18 yrs and < 71 yrs. Transradial amputation or Congenital Hand Hypoplasia Amputation in the chronic stable phase Good functionality of muscles of the stump Absence of severe stump pain (VAS<3) Exclusion Criteria: Cognitive impairment Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I Pregnancy History of or active substance abuse disorder Acquired brain injury with residual impairment Intellectual Disability (IQ < 70) Prior neurological or musculo-skeletal disease Current or prior dermatological conditions Excessive sensitivity to electrical stimulation (people afraid of electrical stimulation or pain) Persons with other diseases that may affect the function of the nervous system. (Diabetes, HIV, Renal Failure) Persons with pacemakers People affected by autoimmune and chronic infective diseases in treatment with immunosuppressive drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Hand<br>The two patient enrolled will perform the task requiring the use of the robotic hand. | Device: Robotic Hand<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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); | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputees