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NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS

NCT02848846 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-07-29

No results posted yet for this study

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.

Conditions

  • Sensorized Hand Prosthesis

Interventions

DEVICE

Robotic Hand

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.

Sponsors & Collaborators

  • Paolo Maria Rossini

    lead OTHER

Principal Investigators

  • paolo m rossini, professor · Catholic University of the Sacred Heart

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-06-30
Completion
2018-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02848846 on ClinicalTrials.gov