Mapping the Neuroplasticity of Patients Affected by Chronic Temporomandibular Disorders on fMRI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- fmri Blood Oxygen Level-Dependent (BOLD)
研究概览
简要总结
Temporomandibular disorders (TMD) are among the most common causes of chronic pain worldwide. It is estimated that about 5-12% of the global population is affected, and some conditions, such as arthritis, may be causative factors. Depending on severity, the joints involved can affect multiple functions of the masticatory system, such as the ability to speak, chew, swallow, limit facial expressions, and even breathe. Moreover, most patients with TMD may report painful conditions in other parts of the body, with comorbidities including chronic fatigue syndrome, chronic headache, endometriosis, fibromyalgia, interstitial cystitis, irritable bowel syndrome, back pain, sleep disorders, and vulvodynia. Another significant condition that frequently occurs alongside TMD is psychological distress in the form of anxiety and/or depression.
The study proposed by this research protocol aims to investigate the presence of TMD and associated psychological/psychiatric disorders such as anxiety and depression. The innovative value of the research lies in evaluating whether the association between these disorders may lead to neuroplastic changes at the brain level, which could guide targeted therapies. Only a few studies in the literature have explored this possible association, with inconclusive and conflicting results.
The study will be prospective in design, based on reference clinical/diagnostic criteria and functional neuroimaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Afflicted with temporomandibular disorder (TMD) associated with chronic pain diagnosed by an experienced specialist among the authors; the disorder, to be considered chronic, must have been present for at least six months.
- •Patients with adequate sensorimotor abilities to participate in the study. This included sufficient vision to read from a computer or tablet screen at a normal distance, sufficient hearing ability to understand normal language, and sufficient motor ability to control a table mouse or computer.
排除标准
- •Control subjects, participating voluntarily in the study, must have met the following inclusion criteria:
- •Healthy subjects defined as free from temporomandibular disorders or diagnosed psychological and/or psychiatric disorders.
结局指标
主要结局
fmri Blood Oxygen Level-Dependent (BOLD)
时间窗: end of the fmri
Oxygenation concentration (referred to as BOLD). Bold is primarily used on the other hand to conduct function brain mapping. The degree of BOLD is a measure of the neuronal activity.
次要结局
未报告次要终点
研究者
Marco Farronato
CO-Principal Investigator
University of Milan
