Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Pain intensity: momentary change
研究概览
简要总结
This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound 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 trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65, any gender
- •Primary diagnosis of generalized chronic pain or widespread 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
- •History of serious brain injury or other neurologic disorder
- •Poorly managed general medical condition
- •Pregnant or breast feeding
- •Implanted device in the head or neck
- •MRI intolerance or contraindication
- •Brain stimulation (e.g., VNS, TMS) in the past month
- •Lifetime history of a serious suicide attempt (Hooley et al., 2014)
- •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: 1 day At stimulation visit
Computerized Visual Analogue Scale. The scale is measured using a continuous slider. At its left boundary, the slider indicates no pain (score 0). At its right boundary, the slider indicates worst pain imaginable (score 100). A lower score indicates a better treatment outcome.
Pain intensity: subjective state
时间窗: 1 day At stimulation visit
PROMIS scale of pain intensity. Scores range from 1 (no pain) to 5 (severe pain). A lower score indicates a better treatment outcome.
Target engagement: brain activation
时间窗: 1 day At MRI study visit
MRI quantification of blood oxygenation level dependent (BOLD) activation.
Anxiety scale: subjective state
时间窗: 1 day At stimulation visit
PROMIS scale of anxiety. Scores range from 1 (not at all anxious) to 5 (severely anxious). A lower score indicates a better treatment outcome.
Target engagement: brain connectivity
时间窗: 1 day At MRI study visit
Pearson's correlation of BOLD signals between the stimulated target and connected regions.
Depression scale: subjective state
时间窗: 1 day At stimulation visit
PROMIS scale of depression. Scores range from 1 (not at all depressed) to 5 (severely depressed). 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