Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS) 0-10 Pain Rating
研究概览
简要总结
The placebo effect is a phenomenon that has experienced major advances of its understanding in the last decade. However, mechanisms of placebo analgesia in chronic pain patients have yet to be compared to healthy subjects. The investigators study aims to investigate the magnitude of placebo response and related opioid release in patients that suffer from episodic migraines as compared to healthy controls. In particular, the investigators are looking to map brain activity during placebo analgesia using modern brain imaging techniques such as functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). The investigators hypothesis is that placebo response and the availability of opioid receptors is reduced in chronic migraine patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Migraine patients with aura with acute episodic migraine meeting the IHS Classification ICHD-II criteria, 3-14 migraines per month.
- •History of episodic migraine for at least 3 years
- •Ages 21-50
- •Male or Female
- •Right Handed
- •Matched healthy subjects will also be recruited.
排除标准
- •Other significant disease (systemic or CNS)
- •Pregnancy
- •Claustrophobia
- •Weight >235 lbs (limit of MRI table)
- •Significant drug including alcohol history (> 7 glasses of alcohol per week)
- •Beck Depression Inventory II (BDI-II) score > 25 (moderate to severe depression)
- •Any metal implants incompatible with MRI (including dental bridges, crowns, retainers, orthodontic devices e.g. braces, IUDs, aneurysm clips or other devices, tattoos containing metallic ink, cardiac pacemakers, prosthetic hear valves, other prostheses, neurostimulator devices, implanted infusion pumps, exposure to shrapnel or metal filings, cochlear implants, etc.)
- •Previous significant research related exposure to ionizing radiation.
- •History of allergy or adverse reaction to opioids
- •Significant medical history of such as seizure disorder, diabetes, alcoholism, cardiac disease including coronary artery disease, psychiatric problems; drug addiction, respiratory problems, liver disease, etc.
- •Positive drug of abuse screen (excluding medications currently prescribed for their clinical condition, e.g. opioids, benzodiazepines, etc.)
- •Patients with migraine <72 hours prior to the experiments will not be included to ensure inter-ictal state.
- •Opioids or preventative medication such as topiramate, SSRIs etc.
研究组 & 干预措施
No Intervention
PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.
Saline Injection (Placebo)
PET-fMRI investigation on healthy subjects and patients with migraine. Placebo condition.
干预措施: Placebo (Other)
结局指标
主要结局
Visual Analogue Scale (VAS) 0-10 Pain Rating
时间窗: 1 day
This study will investigate how placebo may reduce experimental pain induced by contact heat. Patients rate heat stimulus intensity on a 0-10 scale, where 0 is no pain, and 10 is most intense pain possible. Data is reported to the placebo condition. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'most intense pain possible'. The patient is asked to mark his pain level on the line between the two endpoints.
次要结局
- PET Diprenorphine(1 day)
- Pain Anticipation fMRI BOLD Signal(1 day)
- Pain Stimulation fMRI BOLD Signal(1 day)
研究者
David Borsook
David Borosook, MD
Mclean Hospital