NCT05763758进行中（未招募）不适用
Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- alpha oscillations
研究概览
简要总结
This study aims to identify spatiotemporal alterations in thalamocortical circuitry functioning in both healthy subjects and patients with chronic pain, combining multimodal neuroimaging.
详细描述
Investigators will pursue this goal in both experimental and clinical models at two sites (Florida State U/FSU & Mass General Hospital/MGH), implementing parallel enrollment of large and diverse samples (140 healthy participants and 60 patients with chronic low back pain/cLBP). Leveraging the fully developed multimodal neuroimaging methodology-simultaneous EEG-fMRI and combined EEG-MEG-fMRI, the investigators will investigate TC dysconnectivity (fMRI) and alpha dysrhythmia (EEG/MEG) during experimental pressure pain and chronic back pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects for both MGH and FSU sites
- •Inclusion Criteria:
- •healthy male and female adults
- •Between the ages of 18 and 60 years
- •Meeting the MRI / MEG / EEG screening criteria
- •Fluent in English; English can be a second language provided that the patients understand all questions used in the assessment measures. This will be asked and judged during the phone screen.
排除标准
- •Current or past history of major medical, neurological, or psychiatric illness based on self-report
- •History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)
- •History of head trauma
- •Pregnant or lactating
- •Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
- •Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
- •Active substance abuse disorders (based on subject self-report)
- •Subjects with chronic low back pain (MGH site)
- •Inclusion Criteria:
- •Volunteers 18-60 years of age
- •Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)
- •At least 4/10 clinical pain on the 0-10 LBP NRS
- •Meeting the MRI / MEG / EEG screening criteria
- •Fluent in English; English can be a second language provided that the patients understand all questions used in the assessment measures. This will be asked and judged during the phone screen.
- •Exclusion Criteria:
- •Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)
- •Complicated back problems (eg, prior back surgery, medicolegal issues)
- •The intent to undergo surgery during the time of involvement in the study
- •Current or past history of major medical, neurological, or psychiatric illness based on self-report
- •History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)
- •History of head trauma
- •Pregnant or lactating
- •Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
- •Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
- •Active substance abuse disorders (based on subject self-report)
- •Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents
- •Current use of psychotropic medication
结局指标
主要结局
alpha oscillations
时间窗: baseline
alpha oscillations as measured by EEG and MEG
thalamocortical functional connectivity
时间窗: baseline
functional connectivity between the thalamus and cortex as measured by resting state fMRI
次要结局
- alpha band source(Baseline)
研究者
Jian Kong
Principal investigator
Massachusetts General Hospital
研究点 (2)
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