NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS

NCT02848846 | Unknown

• 1 other identifier: FP7- ICT-2013.9.6
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorized Hand Prosthesis

Keywords

Amputees

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Cortical map changes

  1 year

• Cortical map changes

  1 year

Study Arms (1)

Robotic Hand

EXPERIMENTAL

The two patient enrolled will perform the task requiring the use of the robotic hand.

Device: Robotic Hand

Interventions

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.

Robotic Hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Paolo Maria Rossini: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli

Rome, Lazio, 00168, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 33725672 DERIVED

• 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.

  PMID: 32318562 DERIVED

Study Officials

• paolo m rossini, professor

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Maria M Rossini, Professor

CONTACT

00390635504435; paolomaria.rossini@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 29, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

IT (1)