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NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS

NCT ID: NCT02848846

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sensorized Hand Prosthesis

Keywords

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Amputees

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Robotic Hand

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

Group Type EXPERIMENTAL

Robotic Hand

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paolo Maria Rossini

OTHER

Sponsor Role lead

Responsible Party

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Paolo Maria Rossini

Full Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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paolo m rossini, professor

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Locations

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Fondazione Policlinico Agostino Gemelli

Rome, Lazio, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Maria M Rossini, Professor

Role: CONTACT

Phone: 00390635504435

Email: [email protected]

Facility Contacts

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Paolo M Rossini, Full Professor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33725672 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32318562 (View on PubMed)

Other Identifiers

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FP7- ICT-2013.9.6

Identifier Type: -

Identifier Source: org_study_id