NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS

Not Applicable

• Conditions: Sensorized Hand Prosthesis
• Interventions: Device: Robotic Hand

• Registration Number: NCT02848846
• Lead Sponsor: Paolo Maria Rossini

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-23
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-28
• Last Update Submitted: 2016-07-28
• Study First Posted: 2016-07-29
• Last Update Posted: 2016-07-29
• Primary Completion: 2017-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic Hand	Robotic Hand	The two patient enrolled will perform the task requiring the use of the robotic hand.

Primary Outcome Measures

Name	Time	Method
performance of the robotic hand	1 year	Compliance recognition (percentage of success)

Secondary Outcome Measures

Name	Time	Method
Cortical map changes	1 year	Primary somatosensory area (change of dimension and shape);

Trial Locations

Locations (1)

Fondazione Policlinico Agostino Gemelli; 🇮🇹 Roma, Lazio, Italy