ClinicalTrials.gov
ClinicalTrials.gov Menu

NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS (NEBIAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02848846
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Paolo Maria Rossini, Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment Phase
Sensorized Hand Prosthesis Device: Robotic Hand Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2018

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.





Primary Outcome Measures :
  1. performance of the robotic hand [ Time Frame: 1 year ]
    Different level of pressure (percentage of success);

  2. performance of the robotic hand [ Time Frame: 1 year ]
    Virtual egg test (percentage of success);

  3. performance of the robotic hand [ Time Frame: 1 year ]
    Pick and Lift (percentage of success);

  4. performance of the robotic hand [ Time Frame: 1 year ]
    Texture recognition (percentage of success);

  5. performance of the robotic hand [ Time Frame: 1 year ]
    Shape recognition (percentage of success);

  6. performance of the robotic hand [ Time Frame: 1 year ]
    Compliance recognition (percentage of success)


Secondary Outcome Measures :
  1. Cortical map changes [ Time Frame: 1 year ]
    Primary motor area (change of dimension and shape);

  2. Cortical map changes [ Time Frame: 1 year ]
    Primary somatosensory area (change of dimension and shape);



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848846


Contacts
Contact: Paolo Maria M Rossini, Professor 00390635504435 paolomaria.rossini@policlinicogemelli.it

Locations
Italy
Fondazione Policlinico Agostino Gemelli Recruiting
Roma, Lazio, Italy, 00168
Contact: Paolo M Rossini, Full Professor    00390635504435    paolomaria.rossini@gmail.com   
Sponsors and Collaborators
Paolo Maria Rossini
Investigators
Principal Investigator: paolo m rossini, professor Catholic University of the Sacred Heart

Responsible Party: Paolo Maria Rossini, Full Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02848846     History of Changes
Other Study ID Numbers: FP7- ICT-2013.9.6
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by Paolo Maria Rossini, Catholic University of the Sacred Heart:
Amputees