跳至主要内容
临床试验/NCT02747940
NCT02747940已完成4 期

Neurologic Signatures of Chronic Pain Disorders

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
1
主要终点
clinical improvement after treatment (2) headache/pain frequency [attacks per month]

研究概览

简要总结

"Brain signatures" as objective measures of acute pain have been characterized with functional magnetic resonance image and machine learning technology. As compared to acute pain, chronic pain leads to greater socioeconomic burden. However, measures for chronic pain remain subjective and suboptimal, and the brain signatures for chronic pain are largely unknown. Chronic migraine and fibromyalgia are two prototypes primary chronic pain disorders with high disability and intractability with prevalence of around 2% for both diseases. These two chronic pain disorders have shared clinical presentations (abnormal pain sensitivity, mood and sleep disorders), pathophysiology (central sensitization) and medical treatment (anti-depressants), despite different body parts are involved (head vs. whole body). The present integrated project aims to characterize both common and disease-specific brain signatures of chronic pain by investigating these two chronic pain disorders. Our findings may shed some light on the key mechanisms of pain chronification, and may pave the way for the optimization of diagnosis and prognostication, as well as formulation of personalized medicine in chronic pain, so as to improve life quality of these patients and to reduce socioeconomic loss.

The present project includes three interdisciplinary sub-projects (plus one animal study, not listed here):

A: Clinical studies for chronic migraine and fibromyalgia: endophenotypes and pain chronification B: Functional neuroimaging of chronic pain: multimodal quantitative analysis of brain connectomes C. Data stream mining technology for multimodal physiological signals of chronic pain: real-time tracking and clinical correlation

The specific aims of the present projects include:

  1. Identification of common and disease-specific brain signatures for chronic pain (sub-projects A, B, C)
  2. Investigation of clinical indicators with predictive values by machine learning analysis of big data (sub-projects A, B, C)
  3. Elucidation of the specific anatomical structures or neural networks underpinning pain chronification based on clinical neuroimaging (sub-projects A, B) In this 1st-year pilot study of the 4-year longitudinal study, we will establish experimental platforms for each sub-project, start to recruit participants and perform endophenotyping, as well as have a preliminary integration for sub-projects A, B and C.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Control: devoid of any systemic or neurological diseases
  • Chronic migraine: by ICHD-III (International Classification of Headache Disorder) criteria
  • Fibromyalgia: by ACR (American College of Rheumatology) 2010 criteria

排除标准

  • history of major systemic illness, including uncontrolled hypertension, diabetes, chronic renal insufficiency, autoimmune diseases or malignancies
  • history of neurological disorders which might affect sensation such as previous stroke or peripheral neuropathy
  • history of substance abuse (except painkillers)
  • heavy smokers (with a daily consumption >20 cigarettes)
  • pregnancy or lactation
  • any contraindication for magnetic resonance imaging (MRI)
  • and any obvious infection or inflammation over a period of at least 1 month before the study.

研究组 & 干预措施

patients with chronic migraine

Experimental

flunarizine for patients with chronic migraine

干预措施: flunarizine and/or pregabalin (Drug)

patients with fibromyalgia

Experimental

pregabalin for patients with fibromyalgia

干预措施: flunarizine and/or pregabalin (Drug)

patients with chronic migraine and fibromyalgia

Experimental

flunarizine and pregabalin for patients with chronic migraine and myalgia

干预措施: flunarizine and/or pregabalin (Drug)

结局指标

主要结局

clinical improvement after treatment (2) headache/pain frequency [attacks per month]

时间窗: 4 months

clinical improvement (headache/pain frequency) after treatment unit: attacks per month analysis: comparing the mean headache/pain frequency in each month after treatment (M1/M2/M3/M4) to that before treatment (M-1)

clinical improvement after treatment (3) headache/pain duration [hours per day]

时间窗: 4 months

clinical improvement (headache/pain duration) after treatment unit: hours/day analysis: comparing the mean headache/pain duration (hours/day) in each month after treatment (M1/M2/M3/M4) to that before treatment (M-1)

clinical improvement after treatment (1) headache/pain intensity [NRS, numeric rating scale]

时间窗: 4 months

clinical improvement (headache/pain intensity) after treatment unit: NRS (numeric rating scale, 0-10) analysis: comparing the mean headache/pain intensity in each month after treatment (M1/M2/M3/M4) to that before treatment (M-1)

次要结局

  • EEG change after treatment(4 months)
  • sensory and pain threshold change after treatment(2 months)
  • Autonomic function change after treatment(2 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验