A Double-Blind, Placebo-Controlled Cross-Over Study In Fibromyalgia Subjects To Examine Effects Of Pregabalin On Brain Response To Mechanical Pain As Assessed By Functional Magnetic Resonance Imaging, Proton Magnetic Resonance Spectroscopy And Subjective Ratings
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)
研究概览
简要总结
The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance imaging) is an efficient way to show whether new pain medications are effective in treating fibromyalgia.
详细描述
Methodology study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women must have pain due to fibromyalgia
- •Fibromyalgia must have been diagnosed at least 6 months prior to be eligible for this study
排除标准
- •Patients with severe depression or other serious illness, who are left-handed, or who are pregnant or nursing are not eligible for this study.
研究组 & 干预措施
Pregabalin, then placebo
干预措施: Pregabalin, then placebo (Drug)
Placebo, then pregabalin
干预措施: Placebo, then pregabalin (Drug)
结局指标
主要结局
Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)
时间窗: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Single voxel spectra obtained from the anterior and posterior right insula at rest to compare ratios for Gln/Cr, Glu/Cr, and combined Glutamate + Glutamine (Glx/Cr) for pregabalin and placebo. Gln, Glu, Glx calculated as ratios to the internal standard creatine.
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers
时间窗: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined Region of Interest (ROI) brain regions in response to blunt pressure pain; acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kilograms \[kg\] pressure/equal stimulus conditions, and high pain pressure/up to 10 kg). Estimated as magnitude (percent change) of the betas representing brain signal activation associated with pressure induced pain. Any observation with a studentized residual \>3 or \<-3 was considered an outlier.
次要结局
- Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli(Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions(Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Gracely Box Scales for Pain Intensity (GBSint) Including Outliers(Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers(Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers(Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers(Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers(Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers(Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers(Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers(Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51))
- Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked(Day 58)
- Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria(Day 58)