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临床试验/NCT02224469
NCT02224469已完成不适用

Utrecht Neural Prosthesis (UNP): A Pilot Study on Controllability of Brain Signals and Application in locked-in Patients

UMC Utrecht2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年9月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
UMC Utrecht
入组人数
6
试验地点
2
主要终点
Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance

研究概览

简要总结

In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. These brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.

详细描述

In this pilot study we will provide locked-in people with a new means of communication which has not been possible up to now. For the first time, we will test whether we can record and decode neural signals obtained directly from the brain, for control over a computer. The target population is people with locked-in syndrome. For these patients there is no technique available to allow them to communicate unaided. We have developed a brain-computer interface (BCI) system that can read activity directly from the brain, and can convert the activity to a digital switch. The system, called the Utrecht Neural Prosthesis (UNP), consists of an implantable amplifier for electrical brain signals, a set of electrodes positioned on the surface of the brain and a wireless receiver, placed outside of the body. A dedicated computer will convert the signals to electrical pulses for standard Assistive Technology devices. The UNP can in principle enable the patient to engage in any activity that is offered by commercial Assistive Technology companies that can be performed with switch signals, for instance operating home apparatus or writing text. Most importantly, we aim to achieve unsupervised function of the BCI, meaning that the patient will be able to use it at home without the aid of researchers or other experts (but with minimal caregiver assistance).

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 - 75
  • Locked-in status (i.e. severely paralyzed with communication problems)
  • in case of trauma or stroke: at least 1 year after the event
  • in case of a neuromuscular disease: slow progression allowed
  • Rudimentary form of communication possible (e.g. through assistive technology, eye blinks or eye movements, severely impaired speech)
  • Mentally and physically capable of giving informed consent
  • Lives in or close to the Netherlands
  • MR compatible
  • able to lie flat in the scanner
  • no metal objects in or attached to the body
  • no claustrophobia
  • Visus (largely) intact
  • Cognition intact (IQ>80)
  • Compatible with implantation procedure
  • good respiratory function or stable respiratory situation using ventilation assistance

排除标准

  • Strong and frequent spasms
  • Vital indication for blood thinners
  • Current brain tumor or history of tumor resection
  • Quick medical or neurological deterioration
  • Patients who are considered legally incapable (and who therefore will not be able to give informed consent)
  • Current or recent psychiatric disorder
  • Catabolic state
  • Allergy to the materials of the implant

研究组 & 干预措施

ECoG (electrocorticography) sensing

Experimental

Use ECoG-based Brain Computer interface to control assistive technology

干预措施: ECoG (electrocorticography) sensing (Device)

结局指标

主要结局

Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance

时间窗: up to 1 year

The system correctly detects a switch brain signal within 10 sec in a real life, cognitively engaging context, such as operating a spelling device. A formal test has been designed, in which the patient has to copy a 30 character sentence within 30 minutes, with a margin of 20% faulty characters.

次要结局

  • Patient Device Satisfaction(8 years)
  • Effects Device on Quality of Life(3 years)
  • Quality of Life by Scoring Subjective Well-being in ACSA Score(4.5 years)
  • Hours of Use of BCI Device Per Day(Time frame starts when participant receives a system with the full feature set for 24h home use and ends when signal decline starts influencing hours of use per day, an average of 1 year)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erik Aarnoutse, PhD

Study Coordinator

UMC Utrecht

研究点 (2)

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