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临床试验/NCT03052244
NCT03052244Unknown不适用

tDCS Stimulation Combined With VI as a Possible Therapy for Enhancing Functional Ability in SCI With Neuropathic Pain

Loewenstein Hospital0 个研究点目标入组 100 人开始时间: 2017年3月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
change in SCIM 3 (scale)

研究概览

简要总结

Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) will be applied for patient who suffer from neuropathic pain following spinal cord injury The tDCS treatment will be coupled with a video of a man walking (creating a visual illusion) in order to enhance functional ability and reduce pain

详细描述

Non-invasive cortical brain stimulation is a promising method for treating cases of neuropathic pain in patients with spinal cord injury (SCI). Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) appears to modulate cortical excitability and can reduce pain levels following SCI, however its effects remaining for short-term and may not be useful for the rehabilitation progress in these patients.

Recent findings suggest that M1 stimulation combined with visual illusion (VI) enhances the reduction in pain which maintain up to 3 month following treatment. The current study aims to reveal whether reduction of neuropathic pain in patients with SCI through tDCS have beneficial effect on functional ability during rehabilitation program.

In the present study the investigators will use anodal stimulation of the M1 via neuroConn DC stimulator. Current intensity of 2mA or sham stimulation will be given during 20 min in parallel to a visual illusion of walking legs (or neutral video for sham stimuli).

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
Double (Participant, Outcomes Assessor)

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 hospitalized in spinal cord rehabilitation department
  • neuropathic pain following spinal cord injury
  • able to seat on a wheel chair
  • able to understand and comply with basic instructions
  • Hebrew speakers

排除标准

  • non-neuropathic pain
  • medical condition that affect cognitive functioning
  • medical condition other then the spinal cord injury that affect functioning

结局指标

主要结局

change in SCIM 3 (scale)

时间窗: up to 7 day before and following the treatment

spinal cord independence measure

次要结局

  • change in VAS (Visual Analog Scale)(up to 7 day before and following the treatment)
  • change in BPI (Brief Pain Inventory)(up to 24h before and following the treatment)

研究者

发起方
Loewenstein Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

motti ratmansky

Director, Pain Unit

Loewenstein Hospital

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