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临床试验/NCT03644394
NCT03644394已完成不适用

Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees

Medical University of Vienna0 个研究点目标入组 3 人开始时间: 2014年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3
主要终点
Change in hand function over time

研究概览

简要总结

The Implantable Myoelectric Sensors (IMES) system is an investigational device intended to improve signal quality and consistency of myoelectric signals for prosthetic control in individuals suffering from an above elbow (transhumeral) amputation. The sensors pick up myoelectric signals intramuscularly and therefore signal quality is not affected from electrode replacement, perspiration, or artefacts.

详细描述

Implantable Myoelectric Sensors (IMES), the surgical tools implantation, and the external equipment used to control an electromechanical prosthetic device, together comprise the IMES System (investigational product, medical device).

Each IMES acts as an independent differential amplifier consisting of custom electronics housed within a biocompatible, hermetically sealed ceramic cylinder with metal end caps. The end caps serve as electrodes for picking up EMG activity during muscle contraction. Reverse telemetry (via a coil around the arm) is used to transfer data from the implanted sensor, and forward telemetry is used to transmit power and configuration settings to the sensors. The coil and associated electronics are housed within the frame of a prosthesis. A control system that sends data associated with muscle contraction to the motors of the prosthetic joints is housed in a belt-worn, battery-powered device. A cable attaches the control unit to the prosthetic frame.

An IMES is implanted into each targeted muscle that will be used to control a function of the prosthetic arm. Two IMES devices are needed for each DOF. For example, one device would control fingers opening and another device would control fingers closing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • unilateral transhumeral amputation
  • can speak and comprehend German
  • undergone amputee rehabilitation, including being trained to wear and use a conventional myoelectric prosthesis
  • residual upper limb meets the criterions for TMR surgery

排除标准

  • Known genetic neuromuscular disorder
  • bleeding or clotting disorder
  • active implant
  • any metal fragments or metal implants located within the residual upper limb stump
  • Female patients if pregnant or breast-feeding

研究组 & 干预措施

Implantation

Other

Surgical Implantation of IMES sensors

干预措施: Implantation of IMES sensors (Device)

结局指标

主要结局

Change in hand function over time

时间窗: at 3, 6, 9 and 12 months after final prosthetic fitting

Southampton Hand Assessment Procedure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Salminger

Subinvestigator

Medical University of Vienna

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