Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - A Study of Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Volume of the caudate nuclei, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2.
研究概览
简要总结
The purpose of this prospective study is to investigate the degree of association between the volume of important pain-relevant structures in the brain and the size of the areas of secondary hyperalgesia.
详细描述
The healthy study participants will be included from the cohort of a previous study (NCT02527395) where areas of secondary hyperalgesia, heat pain detection thresholds, pain during 1 min. thermal stimulation and test results from the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Score will be retrieved. The study consists of 1 study day. The study day will be conducted at a maximum of 2 months and a minimum of 2 weeks after the completion of the previous study (NCT02527395).The results of the previous study (NCT02527395) will be blinded until all participants have completed the study day.
All study participants will complete a MRI-scan of the brain.
The MRI scans will be performed with a Siemens MAGNETOM Verio 3 tesla, with b17 software, and a 32-channel head coil. The MRI-scan sequence is as follows:
- 3D Localiser
- 3D T1 weighted iso
- AX Diffusion tensor imaging
- AX Epi resting state fMRI
- AX Gre field map
- AX Epi ASL
- AX T2-weighted blade
- AX T2-weighted flair
- AX T2-weighted* Gre
Total MRI-scan time is estimated to approximately 40 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age >18 years and <35 years
- •Speak and understand Danish
- •Study participants who have understood and signed the informed consent
- •No prescription medicine during the last 30 days.
- •Have participated and completed the study with the identifier: NCT02527395.
排除标准
- •Study participants that cannot cooperate to the test.
- •Study participants who have a weekly intake of >21 units of alcohol, or a have consumed >3 units of alcohol within 24 hours before experimental day.
- •Study participants with a substance abuse, assessed by the investigator.
- •Study participants, who have consumed analgesics less than 3 days before experimental day.
- •Study participants, who have consumed antihistamines less than 48 hours before experimental day.
- •Study participants, who have consumed antidepressant medication during the last 30 days before experimental day.
- •Study participants with chronic pain.
- •Study participants with neurological illnesses.
- •Study participants with psychiatric diagnoses.
- •Study participants with a Body Mass Index of >30 kg/m2 or <18 kg/m2
- •Study participants with Contraindications to MRI
- •Study participants that decline information regarding potential pathological findings in relation to the MRI.
- •Study participants that have any kind of trauma resulting in pain and administration of analgesics in the period between experimental pain testing and MRI-scan.
- •Study participant that experience a head trauma in the period between the experimental pain testing and the MRI-scan.
结局指标
主要结局
Volume of the caudate nuclei, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2.
时间窗: 40 minutes
To investigate how close the volume of Caudate nucleus of the right and left hemisphere is associated with the size of the area of secondary hyperalgesia induced by Brief Thermal Sensitization.
次要结局
- Volume of cortical and subcortical areas, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2.(40 minutes)
- White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2(40 minutes)
研究者
Morten Sejer Hansen
M.D.
Rigshospitalet, Denmark