Investigation of Accelerated LIFU: Towards Therapeutic Use for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pain sensation
研究概览
简要总结
This research project is examining the effects of noninvasive brain stimulation on chronic pain. We believe this study will help us to better understand possible treatments for chronic pain patients. Subjects will undergo functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, which is a way to take pictures of the brain and skull. Subjects will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Subjects will undergo pain testing using a small device that will increase the temperature of their skin and will rate this pain. Brain signals (EEG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored. Subjects will complete behavioral questionnaires. Each study session is expected to take 1.5-3 hours. Total participation takes 10 weeks.
详细描述
This is a 2-arm, sham-controlled, cross-over design. This study is collected over 5-7 study visits.
Initial Imaging (1): MRI and CT scans, Questionnaires, and QST Testing.
Intervention (2): Sham or verum LIFU application every 10 minutes, totaling in 8 applications. Between LIFU or Sham application quantitative sensory testing (QST) will be performed. Physiological data collection such as EEG, EDA, BP, ECG, and Respiration will be collected throughout the study visit.
Follow-Up Imaging (2-4): Following intervention sessions participants will receive a resting-state MRI. This can occur throughout the 4-weeks following an intervention visit. Participants will be scanned at least once after each intervention session.
Follow-Up Virtual Questionnaires: Following intervention sessions participants will receive a link (or a phone call if preferred) to periodically rate their pain and report on various lifestyle impacts of their chronic pain. Participants will complete these questionnaires at least twice per week in the 2 weeks following an intervention visit. These questionnaires will take less than 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients with a chronic pain diagnosis. Pain must be moderate-to-severe and present for at least 3 months prior to research participation. Patients of all ethnicities, who understand and speak English.
排除标准
- •Claustrophobia (scanning environment may be uncomfortable).
- •Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- •Contraindications to CT: pregnancy
- •Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
- •History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
- •History of head injury resulting in loss of consciousness for >10 minutes.
- •History of alcohol or drug dependence (through self-report).
结局指标
主要结局
Pain sensation
时间窗: during 2 study visits - up to 8 times per visit.
Reduced perceived sensation (pain) score in response to painful stimulus. Pain scale of 0-10, 0 being no pain and 10 being worst pain imaginable.
次要结局
- Quality of Life(4 weeks following each intervention, every 2-4 days, 30 min per day.)
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University