NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS (NEBIAS)

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.

Study Overview

• Status: Unknown
• Conditions: Sensorized Hand Prosthesis
• Intervention / Treatment: Device: Robotic Hand

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Agostino Gemelli
      • Contact: Paolo M Rossini, Full Professor; Phone Number: 00390635504435; Email: paolomaria.rossini@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Robotic Hand; The two patient enrolled will perform the task requiring the use of the robotic hand.

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Paolo Maria Rossini
• Investigators: Principal Investigator: paolo m rossini, professor, Catholic University of the Sacred Heart

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (ESTIMATE): July 29, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Amputees
• Other Study ID Numbers: FP7- ICT-2013.9.6