Structural and Functional Grey and White Matter Changes in Patients With Pain Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The exact lesion location in the thalamus in patients with thalamic pain compared to patients with thalamic stroke without pain
研究概览
简要总结
The goal of this observational study is to examine the association between exact lesion location and presence of thalamic CPSP (Central post-stroke pain) in a larger number of patients after thalamic stroke.
详细描述
The researchers will explore how the brain areas and mechanisms of brain plasticity are involved in the generation of thalamic CPSP, compared to other pain disorders, using structural and functional magnetic resonance imaging (MRI) at 3 Tesla. The functional magnetic resonance imaging (fMRI) will be also used to assess the cerebral processing of heat/cold stimuli in patients with thalamic pain compared to thalamic stroke patients without pain, to patients with migraine (other central pain disorder) and to normal controls. In addition the researchers want to assess the somatosensory profile of thalamic pain patients and compare it with thalamic stroke patients without pain, patients with migraine (pain control) and normal controls.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with thalamic central post-stroke pain (CPSP) :
- •Patients fulfilling all of the following inclusion criteria are eligible for the study:
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •History of thalamic stroke (infarction or bleed)
- •Diagnosis of definite central-post stroke pain (according to the criteria proposed by Klit et al, 2009)
- •No other chronic pain condition
- •Age: ≥18 years old
- •Patients with thalamic stroke without CPSP:
- •Patients fulfilling all of the following inclusion criteria are eligible for the study:
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •History of thalamic stroke (infarction or bleed), at least 2 years ago
- •No chronic pain condition (neither CPSP or other pain condition)
- •Age ≥18 years old
- •Patients with migraine (other pain condition):
- •Patients fulfilling all of the following inclusion criteria are eligible for the study:
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •History of highly frequent (≥8 monthly migraine days) or chronic migraine (≥15 monthly migraine days).
- •No history of stroke
- •Age ≥18 years old
- •Healthy controls:
- •Participants fulfilling all of the following inclusion criteria are eligible for the study:
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •No history of stroke
- •No chronic pain condition
- •Age: ≥18 years old
排除标准
- •History of severe neurological, internistic or psychiatric disease
- •MRI related exclusion criteria:
- •paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the brain)
- •Pacemaker
- •Claustrophobia
- •Pregnancy
结局指标
主要结局
The exact lesion location in the thalamus in patients with thalamic pain compared to patients with thalamic stroke without pain
时间窗: One time assessment with a duration of max. 90 minutes.
To determine the mutual lesion location in patients with CPSP of thalamic origin in standard stereotactic space using high-resolution 3 T MRI data and to calculate odds ratio maps for the risk of developing CPSP of thalamic origin with lesion of specific areas of the thalamus.
次要结局
- Functional brain changes regarding the central processing of heat/cold stimulation in patients with thalamic pain compared to the other patient groups and the healthy controls(One time assessment with a duration of max. 90 minutes.)
- Functional brain changes regarding the connectivity of pain networks in patients with thalamic pain compared to the other patient groups and the healthy controls(One time assessment with a duration of max. 90 minutes.)
- Structural white matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls(One time assessment with a duration of max. 90 minutes.)
- Somatosensory profile of patients with thalamic pain vs. migraine (pain-control-group)(One time assessment with a duration of max. 60 minutes.)
- Structural gray matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls(One time assessment with a duration of max. 90 minutes.)