跳至主要内容
临床试验/NCT02678494
NCT02678494已完成不适用

Home Based Brain-Train Treatment of Central Neuropathic Pain Following Spinal Cord Injury

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年6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
入组人数
10
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

A study examining the effectiveness of neurofeedback therapy for the treatment of Central Neuropathic Pain (CNP), in patients with a Spinal Cord Injury, using a small user-friendly device which can be operated by patients at home.

详细描述

Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation from the body. SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP). This pain typically develops several months after the injury.

In 30% to 40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system.

In a previous study, some characteristic 'signatures' of brain waves that are related to CNP were defined. Based on this, a novel treatment for CNP based on neurofeedback was developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to record patients' brain waves and shown to patients on a computer screen in a simple graphical form (e.g. bars). Patients were trained to change their brain activity at will and, as a consequence, their pain was reduced. Costly laboratory devices were used and once the study was over, an adequate alternative could not be offered to patients.

In this study, a cheap, portable, wireless and user friendly, Conformité Européenne (CE) marked EEG device will be used to train 10 patients to self-administer the therapy in the comfort of their homes. Participants will be given initial training to use the equipment then will be asked to use the system at home for 3 months - initially, 3-5 times a week then, if/when pain subsides, at least once a week or as required.

The primary purpose of the study is to determine whether a portable system for neuromodulation is a useful tool for administering therapy for pain (intensity of pain will be measured by the visual numerical scale (VNS)).

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • normal or corrected to normal vision
  • no history of brain disease or injury
  • incomplete/complete injury at level C5 to T12
  • central neuropathic pain (below the level of injury)
  • intensity of pain 4 or above (VNS)
  • stable medication regime (expected not to change during the period of the study), responding to some extent to CNP medication treatment
  • patient or caregiver minimum computer literacy (owning a computer, laptop, tablet, ipad etc)

排除标准

  • chronic or acute muscular or visceral pain larger than 4 VNS
  • diagnosed mental health problems
  • active intervention of pain team (changing existing treatments)

研究组 & 干预措施

Neurofeedback training

Experimental

Neurofeedback training: self-administered at home for 3 months. 3-5 sessions per week initially, then at least once a week. Each session consists of 5-6 blocks of 5 minute training.

干预措施: Neurofeedback training (Other)

结局指标

主要结局

Pain intensity

时间窗: Baseline and 3 months

Change in intensity of pain as measured by the Visual Numerical Scale

次要结局

  • Brain activity(Baseline and 3 months)
  • Patients' perspective of home-based neuro-therapy training(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Brain-Train Home Based Pain Treatment | 临床试验