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临床试验/NCT02740062
NCT02740062Unknown不适用

A Novel Non Invasive Brain EEG Based Evaluation and Treatment for Central Manifestation Characteristics of Neuropathic Pain

NIBS NeuroScience Technologies2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Change in pain as measured by VAS (visual analog scale)

研究概览

简要总结

This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for evaluation and treatment of neuropathic pain. The NIBS system evaluates brain neuronal network activity and customizes a personalized treatment utilizing low current non invasive brain stimulation technology for neuropathic pain with central component. this is single meeting trial which includes brain activity evaluation and a single treatment and sham treatment. The goal of the study is to evaluate the central brain component of neuropathic pain subjects, and the effect of conventional tDCS treatment.

详细描述

Neuropathic pain is a pain which persists after nerve injury has healed and results from significant functional and structural changes in the nervous system similar to memory processes. As a result, neuropathic pain has been proposed to be "a persistence of the memory of pain and/or the inability to extinguish the memory of pain evoked by an initial inciting injury". A firm conclusion in the neurobiology of learning and memory is that different types of memory have distinct mechanisms (e.g., declarative memory vs procedural memory). A similar distinction can be made in pain: various chronic pain states have distinct central mechanisms . Accumulating evidence suggests that chronic pain is a type of nociceptive memory mediated by structural and functional plasticity in by multiple pathways at cortical, subcortical, spinal, and peripheral levels.Elucidating the basal neuronal signature of the person suffering from chronic pain enables to optimizing a treatment which in all studies was constant for all patients regardless of their basal activity

In this study participants will undergo diagnosis of the personalized central manifestation characteristics of the neuropathic pain and evaluate the efficacy of a standard, most commonly used tDCS treatment, based on the diagnosis.

for this purpose a single meeting will take place during which participants will undergo evaluation, sham treatment and standard tDCS treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Neuropathic pain diagnosis by pain physician Up to 3 months before trial onset.
  • Current NPRS>4

排除标准

  • Neurological illness causing structural brain damage (e.g. Stroke, TIA)
  • Psychiatric disease
  • History of loss of consciousness
  • Epilepsy or epilepsy in a first degree relative
  • Medical implants
  • Pregnancy

结局指标

主要结局

Change in pain as measured by VAS (visual analog scale)

时间窗: Before and 10 minutes after one time treatment

VAS estimation before Treatment and 10 minutes after tDCS treatment.

次要结局

  • Von Frey sensitivity evaluation in neuropathic area(Before and 10 minutes after one time treatment)

研究者

发起方
NIBS NeuroScience Technologies
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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