Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States
研究概览
简要总结
The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fMRI).
详细描述
Currently there are no pharmacological agents that can control neuropathic pain akin to the efficacy of antibiotics for bacterial infection. All current neuropathic pain drugs have approximately the same efficacy of less than 30% in controlled trials, and many of these drugs do not have known mechanisms of action. fMRI studies may provide insight into how brain circuitry is altered by chronic pain, and how these drugs act on altered circuitry. The trigeminal system in particular offers unique advantages for studying such alterations, including a large central representation and high degree of somatotopy. The administration of lamotrigine to neuropathic pain patients in conjunction with fMRI will allow us to compare subjective ratings of pain with objective measures of neural activity during increased conditions of allodynia/hyperalgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •Right-handed non-smokers
- •Diagnosed with facial pain
- •Continuous pain for more than 3 months
- •Spontaneous pain greater than 3 of 10
- •Allodynia to brush greater than 5 of 10
排除标准
- •Medications
- •Depression
- •Significant medical problems
- •Claustrophobia
- •Abnormal EKG
- •Significant drug or alcohol history
- •Positive drug screen
- •Weight greater than 285 lbs
- •History of allergy to anticonvulsants
- •Tattoos with metallic ink on upper body
- •Any neurostimulator devices, or metal cochlear, ocular, or cardiac implants or other metal near vital areas
- •Exposure to shrapnel or metal filings
- •Other metallic surgical hardware
研究组 & 干预措施
Lamotrigine to Placebo Crossover
The drug lamotrigine will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, placebo (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for placebo will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.
干预措施: Lamotrigine (Drug)
Placebo to Lamotrigine Crossover
The placebo will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, the drug lamotrigine (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for drug will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.
干预措施: Placebo (for Lamotrigine) (Drug)
结局指标
主要结局
Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States
时间窗: Week 10 during scanning session
fMRI scans acquired Stimuli Type: Brush Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness fMRI scans acquired Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness \*\*Extra time allotted for probe repositioning\*\* fMRI scans acquired Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness \*\*Extra time allotted for probe repositioning\*\* Cortical, subcortical, and brain stem sensory regions Z-scores Increase or decrease in activation as affected by the drug
次要结局
- Subjective Ratings of Pain During Magnetic Resonance Scanning(week 10 (during the scan))
研究者
David Borsook, M.D., Ph.D.
Dr.
Pain and Analgesia Imaging and Neuroscience Group