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NEBIAS: NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS

Sponsor
Paolo Maria Rossini (Other)
Overall Status
Unknown status
CT.gov ID
NCT02848846
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
30
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Robotic Hand
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. performance of the robotic hand [1 year]

    Different level of pressure (percentage of success);

  2. performance of the robotic hand [1 year]

    Virtual egg test (percentage of success);

  3. performance of the robotic hand [1 year]

    Pick and Lift (percentage of success);

  4. performance of the robotic hand [1 year]

    Texture recognition (percentage of success);

  5. performance of the robotic hand [1 year]

    Shape recognition (percentage of success);

  6. performance of the robotic hand [1 year]

    Compliance recognition (percentage of success)

Secondary Outcome Measures

  1. Cortical map changes [1 year]

    Primary motor area (change of dimension and shape);

  2. Cortical map changes [1 year]

    Primary somatosensory area (change of dimension and shape);

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione Policlinico Agostino Gemelli Roma Lazio Italy 00168

Sponsors and Collaborators

  • Paolo Maria Rossini

Investigators

  • Principal Investigator: paolo m rossini, professor, Catholic University of the Sacred Heart

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Maria Rossini, Full Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT02848846
Other Study ID Numbers:
  • FP7- ICT-2013.9.6
First Posted:
Jul 29, 2016
Last Update Posted:
Jul 29, 2016
Last Verified:
Jul 1, 2016
Keywords provided by Paolo Maria Rossini, Full Professor, Catholic University of the Sacred Heart
Amputees

Study Results

No Results Posted as of Jul 29, 2016