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临床试验/NCT02848846
NCT02848846Unknown不适用

NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS

Paolo Maria Rossini1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
2
试验地点
1
主要终点
performance of the robotic hand

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

Robotic Hand

Experimental

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

干预措施: Robotic Hand (Device)

结局指标

主要结局

performance of the robotic hand

时间窗: 1 year

Different level of pressure (percentage of success);

次要结局

  • Cortical map changes(1 year)

研究者

发起方
Paolo Maria Rossini
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Paolo Maria Rossini

Full Professor

Catholic University of the Sacred Heart

研究点 (1)

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