The Impact of Cerebellar Mass Resection on Pain Processing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Increase in blood oxygen level dependent signal response
研究概览
简要总结
The purpose of the study is to evaluate how cerebellar resection surgery may affect pain sensation and the way the brain "reads" pain signals. By measuring brain activity in children and adolescents following surgery, the investigators hope to gain valuable information about pain processing in the brain.
详细描述
This study is designed to test whether cerebellar resection surgery affects pain pathways in the brain. To participate a participant must (A) have had a cerebellar mass surgically removed, or (B) are a healthy volunteer with no history of pain disorders or mental illness. The study will involve sensory testing and brain imaging using magnetic resonance imaging (MRI) Sensory testing will be performed using a tub of cold water, as well as a contact thermode capable of delivering hot and cold temperatures. MRI brain scanning uses magnetic fields and radio waves to give pictures of the brain without using radiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 38 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Claustrophobia
- •Significant medical (e.g. asthma, renal, cardiac, gastrointestinal or immunological) or brain- related disorders (e.g. seizures, autism, psychiatric conditions such as severe depression, psychosis)
- •Metallic or magnetic implants that pose a risk to the participant or to the data quality
- •Weight > 285 pounds (weight limit of the fMRI table)
- •History of drug abuse or positive drug screen
- •Positive pregnancy screen
- •Use of antidepressants or anticonvulsants, excepting patient usage after resection
- •Significant alcohol history (ingestion of 5 or more glasses (> 40 oz) of alcohol per week)
- •Tattoos containing metallic ink on the neck, shoulders, upper arm and head (which could heat up in the scanner, and potentially cause blistering or burning)
- •Cardiac pacemakers
- •Aneurysm clips and other vascular stents, filters, clips or other devices
- •Prosthetic heart valves
- •Other prostheses
- •Neuro-stimulator devices
- •Implanted infusion pumps
- •Cochlear (ear) implants
- •Ocular (eye) implants or known metal fragments in eyes
- •Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)
- •Participants that require anesthesia to complete an MRI scan
- •Receipt of a medication via transdermal patch
结局指标
主要结局
Increase in blood oxygen level dependent signal response
时间窗: Baseline, Day 1
Functional magnetic resonance imaging scans will be collected to measure blood oxygen level dependent (BOLD) responses, an indirect measure measure of neural activity. The Unit of Measure is % BOLD signal change across spatiotemporal domains within the brain.
次要结局
- Behavior Rating Inventory of Executive Function-Adult version scores(Baseline, Day 1)
- Fear of Pain Questionnaire-Child scores(Baseline, Day 1)
- Multidimensional Anxiety Scale for Children scores(Baseline, Day 1)
- Behavior Rating Inventory of Executive Function scores(Baseline, Day 1)
- Fear of Pain Questionnaire III-Adult scores(Baseline, Day 1)
- Multidimensional Anxiety Questionnaire-Adult scores(Baseline, Day 1)
研究者
Eric Moulton, PhD
Principal Investigator
Dana-Farber Cancer Institute