Clinical trial NCT02848846: NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS
Official title: NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sensorized Hand Prosthesis
Keywords: Amputees
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: performance of the robotic hand
timeFrame: 1 year
measure: performance of the robotic hand
timeFrame: 1 year
measure: performance of the robotic hand
timeFrame: 1 year
measure: performance of the robotic hand
timeFrame: 1 year
measure: performance of the robotic hand
timeFrame: 1 year
measure: performance of the robotic hand
timeFrame: 1 year
Secondary outcomes:
measure: Cortical map changes
timeFrame: 1 year
measure: Cortical map changes
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli
state: Lazio
Study officials:
affiliation: Catholic University of the Sacred Heart
name: paolo m rossini, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.