Deriving Candidate Diagnostic and Prognostic Network Biomarkers for Chronic Pain Using the QuantalX DELPHI TMS-EEG System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- TMS-Evoked Potential Amplitude
研究概览
简要总结
In this study the investigators aim to assess the correlates of neurophysiological measures (measurement of brain magnetically evoked response) using DELPHI system. The DELPHI system device is a computerized, electromechanical medical device that produces and delivers non-invasive Transcranial Magnetic Stimulation (TMS) fields to induce electrical currents directed at regions of the cerebral cortex and records the resultant Electroencephalogram (EEG) brain electrophysiological response. DELPHI analyzes the TMS Evoked Potential (TEP) and produces quantitative output measures.
Objectives include:
- To use TMS-evoked EEG measures of brain function in patients with chronic pain using the QuantalX DELPHI system to predict patient specific pain diagnoses using machine learning classification methods.
- To evaluate longitudinal associations between TMS-evoked EEG measures and ratings of chronic pain.
- To monitor associations between TMS-evoked EEG biomarkers and therapy success for three different classes of medications.
详细描述
Chronic pain is the leading cause of disability worldwide. Patients with chronic pain have highly variable responses to available treatments, leading to trial-and-error based interventions that delay relief, prolong suffering, and increase reliance on potentially addictive opioid analgesics. This hallmark variability between individual patients is a key barrier to the development of reliable biomarkers for diagnosis and treatment selection. Chronic pain is associated with maladaptive reorganization of brain circuits involved in sensory, emotional, and cognitive aspects of pain. However, specific abnormalities and their relationships to personalized outcomes are unknown. Here, the investigators propose to collect measures of brain network connectivity, excitability, and plasticity using the QuantalX DELPHI-MD (TMS-EEG) system to identify mechanistic biomarkers for patient diagnosis and treatment prognosis. This is a prospective, pilot cohort study. Relationships uncovered during analysis of pilot data will be used to support future experimental research and better characterize specific measures that may be useful to collect in ongoing patient outcome research at UCSF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged 18-80 with a diagnosis of chronic pain agreeing to participate in all study procedures. To maximize accrual and phenotypic variability in the sample for planned analyses, we include patients meeting ICD-11 criteria for chronic pain, a duration-based parent code for several common, clinically relevant pain conditions. Patients must have pain lasting more than 6 months.
排除标准
- •Neurologic disorders: Dementia, Severe neurocognitive disorder (MoCA < 22), Severe aphasia, Seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, neoplasms, hydrocephalus, sequelae of meningitis, MS plaques), cerebral palsy, or complete paralysis
- •Major psychiatric disorders (e.g., Bipolar Disorder, Schizophrenia), suicidal thoughts
- •Subjects with any metallic brain implant or fragments (such as shunt, pacemaker, clips, coils, bullet fragments, cochlear implants).
- •Subjects with any implanted devices activated or controlled by physiological signals and/or ferromagnetic or other magnetic sensitive metals implanted in the head or anywhere within 12 inches/30 cm from the stimulation coil.
- •Subjects using medications that may alter electroencephalography (EEG) waveforms, including ketamine and benzodiazepines, are eligible to participate, but will be asked to hold these medications 4-8 hours prior to the study visits, as appropriate.
- •Pregnant or breastfeeding woman.
研究组 & 干预措施
Longitudinal TMS-EEG
Each visit will involve completion of the TMS-EEG intervention.
干预措施: QuantalX DELPHI-MD (TMS-EEG) (Device)
结局指标
主要结局
TMS-Evoked Potential Amplitude
时间窗: Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months)
The QuantalX DELPHI (TMS-EEG) system will be used to generate N45 potential amplitudes from the primary motor cortex. The DELPHI System is used for acquisition of physiological signals of Electroencephalography (EEG) from the scalp in response to magnetic stimulation. It consists of a DELPHI amplifier, a computer (workstation), a patient EEG cap, a transcranial magnetic stimulation (TMS) device and "Figure 8" stimulation coil. To limit the effect of medications on EEG results, participants will be asked to hold medications known to significantly alter EEG waveforms (including ketamine and benzodiazepines) 4-8 hours prior to the study visits, as appropriate. The device can also generate a range of regional and global metrics of brain excitability (e.g., N100 potential amplitudes), plasticity (e.g., change in N45 amplitude after conditioning pulses), and connectivity (e.g., between region coherence) at each scheduled clinic visit.
Visual analog scores (VAS)
时间窗: Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months)
Real time pain intensity and unpleasantness ratings from 0 to 100.
次要结局
- Numerical Rating Scales (NRS)(Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months))
- Pain Body Maps(Visit 1(Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months))
- NIH PROMIS questionnaires(Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months))
- McGill Pain Questionnaire (MPQ)(Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months))
- Pain Catastrophizing Scale (PCS)(Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months))
- Beck Depression Inventory-II (BDI-II)(Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months))
- World Health Organization Disability Assessment Schedule (WHODAS)(Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months))
- Pittsburgh Sleep Quality Index (PSQI)(Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months))