Noninvasive Modulation of Chronic Neuropathic Pain With Focused Ultrasonic Waves
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain intensity: momentary change
研究概览
简要总结
This study will apply low-intensity transcranial focused ultrasound to dorsal root ganglia in patients with chronic neuropathic pain. The target will be validated using magnetic resonance imaging. The stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The level of pain will be evaluated using the Numerical Rating Scale (NSR-11) and the Patient-Reported Outcomes Measurement Information System (PROMIS) numerical rating scales of pain.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of chronic pain
- •Moderate-to-severe chronic pain lasting at least 2 months
- •Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
- •For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
- •Capacity to provide informed consent; provision of a signed and dated consent form
排除标准
- •Poorly managed general medical condition
- •Pregnant or breast feeding
- •Implanted device in the back
- •Lifetime history of a serious suicide attempt
- •Clinically inappropriate for participation in the study as determined by the study team
结局指标
主要结局
Pain intensity: momentary change
时间窗: During the intervention, and every day thereafter, for 7 days
Numerical Rating Scale (NRS-11) of pain. NRS-11 is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Pain intensity: subjective state
时间窗: Immediately after the intervention, and every day thereafter, for 7 days
PROMIS scale of pain intensity. Scores range from 1 (no pain) to 5 (severe pain). A lower score indicates a better treatment outcome.
次要结局
未报告次要终点
研究者
Jan Kubanek
Assistant Professor
University of Utah