Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain in Patients With Diabetic Polyneuropathy Using Proton MR Spectroscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- cerebral neurobiological effect of pregabaline as treatment for neuropathic pain
研究概览
简要总结
Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS):
The aim of our study is to investigate the effect of Pregabalin as a treatment for neuropathic pain in a homogeneous study population, using proton MRS (1H MRS) focusing on four regions of interest (bilateral thalami, rostral anterior cingulated cortex (rACC) and dominant dorsolateral prefrontal cortex (DLPC).
详细描述
spectrum measurements at: thalamus left thalamus right rostral anterior cingulated cortex dominant dorsolateral prefrontal cortex
measurements: gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients with painful DPN
- •Patient willing to provide informed consent
- •Type 1 or type 2 diabetes with HbA1c ≤ 11%
- •Stable antidiabetic medication for 30 days prior to randomization
- •Duration of painful DPN ≥ 3 months
- •Visual analogue scale (VAS) score ≥ 4
排除标准
- •Creatinine clearance ≤ 60mL/min
- •Presence of other clinically significant or disabling chronic pain condition
- •Active malignancy
- •Evidence of an active disruptive psychiatric disorder or other known condition that might influence the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
- •Life expectancy less than 1 year
- •Existing or planned pregnancy
- •Extreme fear for entering MRI
- •General contraindication for MRI (pacemaker, etc...)
- •Patients participating in other clinical trials
- •Age <18 years
- •Prior use of potential retinotoxins
- •Prohibited medications without proper wash-out period (>7days, depending on the type of medication):
- •medications and supplements commonly used for relief of neuropathic pain
- •antiepileptics
- •antidepressants (except for stable regiments of SSRIs for treatment of anxiety or depression)
结局指标
主要结局
cerebral neurobiological effect of pregabaline as treatment for neuropathic pain
时间窗: 1 year
We will measure changes in neurotransmitter levels in the brain (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) before and after treatment with pregabaline. Specific interest in ratio GABA/Gln and GABA/Glu: relationship between inhibitory and excitatory neurotransmittors
次要结局
- cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline(1 year)