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临床试验/NCT02178917
NCT02178917已完成不适用

Neurofeedback Treatment of Central Neuropathic Pain (CNP) in Sub-acute Patients With Spinal Cord Injury (SCI)

NHS Greater Glasgow and Clyde2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年8月27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
20
试验地点
2
主要终点
Intensity of Pain

研究概览

简要总结

Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in 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 30-40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Many patients give up work, not because of the injury, but because of pain. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system.

In previous research, characteristic 'signatures' of brain waves that are probably related to CNP have been 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 these were 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. Patients who had suffered from CNP for years received up to 40 neurofeedback treatment sessions, reducing their pain for several days after each session.

The primary aim of this study is to apply neurofeedback therapy to a larger number of recently injured patients, who are still in a hospital. It is hypothesised that neurofeedback treatment will be more effective in people who have suffered from CNP for a shorter period of time.

The secondary aim of the study is to define EEG predictors of CNP. EEG will be recorded in recently injured patients with no chronic pain, knowing that a certain number of patients will develop CNP within weeks or months. These patients will be followed up for a year and the EEGs of patients who develop CNP will be compared with those who do not.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • Patients with Central Neuropathic Pain (Treatment and Control Groups)
  • Normal or corrected to normal vision
  • No history of brain disease or injury
  • Incomplete/complete spinal cord injury at level C5 to T12
  • Below level neuropathic pain for at least 6 weeks
  • Intensity of pain 4 or above (verbal numeric scale - VNS)
  • Stable medication regime responding to some extent to CNP medication treatment
  • Patients with no chronic pain
  • Normal or corrected to normal vision
  • No history of brain disease or injury
  • Incomplete/complete injury at level C5 to T12
  • Within 23 months post-injury

排除标准

  • Patients with Central Neuropathic Pain (Control and Treatment Groups)
  • Chronic or acute muscular or visceral pain larger than 4 VNS.
  • Diagnosed mental health problems
  • Active intervention of pain team
  • Patients with no chronic pain
  • Chronic or acute pain larger than 3 on the VNS.
  • Diagnosed mental health problems

研究组 & 干预措施

Control: patients with central neuropathic pain

Other

Randomised to no neurofeedback treatment

干预措施: No neurofeedback therapy (Other)

patients with no central neuropathic pain

No Intervention

Observed for development of central neuropathic pain

patients with central neuropathic pain

Experimental

Randomised to 20 neurofeedback therapy sessions

干预措施: Neurofeedback therapy (Other)

结局指标

主要结局

Intensity of Pain

时间窗: 1 year

As measured by a numerical analogue scale

次要结局

  • Changes in EEG activity(1 year)
  • Changes in Spasticity(1 year)
  • Changes in Mood(1 year)
  • Changes in quality of sleep(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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