Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events via a neurological examination
研究概览
简要总结
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-65 years
- •Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months.
- •Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥
- •Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-
- •Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.
- •Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for DSM-5.
排除标准
- •Evidence of neuropathic pain
- •Previous spine surgery
- •Current substance use disorder other than OUD or tobacco use disorder
- •Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
- •Chronic Pain Conditions other than chronic back pain
- •Daily opiate use other than buprenorphine/methadone for OUD/pain control
- •Pregnant or breastfeeding
- •History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
- •History of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome
- •Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
- •Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist
- •Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events via a neurological examination
时间窗: Assessed per participant, over the course of participation - an average of 4 weeks
Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.
Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire
时间窗: Assessed per participant, over the course of participation - an average of 4 weeks
Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.
Changes in Heart Rate (HR)
时间窗: Assessed per participant, over the course of participation - an average of 4 weeks
changes in HR compared pre/post LIFU and at follow up
Changes in Respiration Rate (RR)
时间窗: Assessed per participant, over the course of participation - an average of 4 weeks
changes in RR compared pre/post LIFU and at follow up
Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale.
时间窗: Assessed per participant, over the course of participation - an average of 4 weeks
changes in mood scale compared pre/post LIFU and at follow up
Changes in Blood Pressure (BP)
时间窗: Assessed per participant, over the course of participation - an average of 4 weeks
changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up
次要结局
未报告次要终点
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University