Imaging Glia-mediated NeuroInflammation and Treatment Efficacy (the IGNITE Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Thalamic Standardized Uptake Value Ratio (SUVR)
研究概览
简要总结
In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain. The efficacy of minocycline use for low back pain treatment will also be evaluated by observing whether short-term minocycline administration will reduce neuroinflammation and low back pain symptoms.
详细描述
The goal of this research study is to evaluate whether the central nervous systems of those with low back pain are different from those of healthy, pain-free individuals. Specifically, the researchers will test whether "glial cells" (the immune cells of the brain and spinal cord) are more active in patients with low back pain than in healthy volunteers. The investigators' previous study showed that patients with chronic low back pain demonstrated elevations in brain levels of the 18kDa translocator protein (TSPO), a marker of glial activation.
To test this hypothesis, the study team will image the brains and spinal cords of patients suffering from low back pain using integrated magnetic resonance- positron emission tomography (MR-PET), and a radiotracer called [11C]PBR28, which tracks levels of glial activation.
The efficacy of minocycline as a treatment for chronic low back pain will also be evaluated. A recent study demonstrated a statistically significant reduction in pain in those with lumbar radiculopathy after treatment with minocycline, leading the investigators of this study to believe that minocycline may have potential efficacy in treating other back pain populations.
The study team will observe whether a short course of minocycline hydrochloride may reduce glial activation along with self-reported low back pain symptoms. To this end, patients will be evaluated clinically and/or re-scanned after completing a 2-week trial of minocycline or placebo (a sugar pill).
This study will be enrolling individuals who have been suffering from sub-acute (short-term) and chronic low back pain.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •the ability to give written informed consent
- •fluency in English
- •on a stable pain treatment
- •Chronic or sub-acute low back pain
排除标准
- •no interventional pain procedures during drug trial
- •contraindications to MRI and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)
- •pregnancy or breast feeding
- •any use of recreational drugs in the past 6 months
- •allergy to minocycline or other tetracyclines, or taking medications known to interact with minocycline
- •any other contraindications to minocycline administration
研究组 & 干预措施
Minocycline Arm
Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 2-week trial of Minocycline Hydrochloride, 100mg capsule
干预措施: Minocycline Hydrochloride 100mg Capsule (Drug)
Minocycline Arm
Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 2-week trial of Minocycline Hydrochloride, 100mg capsule
干预措施: Magnetic Resonance-Positron Emission Tomography Imaging (Diagnostic Test)
Placebo Arm
Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after 2 weeks of treatment with a placebo capsule.
干预措施: Magnetic Resonance-Positron Emission Tomography Imaging (Diagnostic Test)
Placebo Arm
Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after 2 weeks of treatment with a placebo capsule.
干预措施: Placebo Capsule (Other)
结局指标
主要结局
Changes in Thalamic Standardized Uptake Value Ratio (SUVR)
时间窗: The outcome measure was assessed in two time points, before and after a two-week treatment period.
The ratio of the standardized uptake value (SUV; mean radioactivity divided by the injected dose by weight) of the whole thalamus divided by the SUV of the whole brain (i.e., standardized uptake value ratio or SUVR) derived from the translocator protein positron emission tomography (TSPO-PET) signal. Higher SUVR might be indicative of higher neuroinflammation.
次要结局
- Changes in Spinal PET Signal(2 weeks)
- Rate of Change in Daily Modified Brief Pain Inventory (BPI) Severity Subscale(2 weeks)
研究者
Marco Loggia
Associate Professor of Radiology and Anesthesiology
Massachusetts General Hospital