Accelerated Low-Intensity Focused Ultrasound (LIFU) for Chronic Pain and Generalized Anxiety Disorder: A Proof-of-Concept Case Series
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety - monitoring of possible symptoms
研究概览
简要总结
A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.
详细描述
A single-arm, open label, 2 cohort (chronic pain/GAD) case study with extended (6 months) follow-up following accelerated low-intensity focused ultrasound for neuromodulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •GAD Symptoms - GAD-7 score >= 10, OASIS score >= 8, or PSWQ score >=
- •OR Chronic pain symptoms - moderate to severe pain, present for at least 3 months.
排除标准
- •Claustrophobia
- •Contraindications to MRI or CT
- •Active medical disorder with CNS effects
- •History of neurologic disorder
- •History of head injury with LOC > 10 minutes
- •Active drug or alcohol dependence
研究组 & 干预措施
Low-intensity focused ultrasound for neuromodulation
Accelerated (repeat) LIFU application for neuromodulation
干预措施: Low Intensity Focused Ultrasound (Device)
结局指标
主要结局
Safety - monitoring of possible symptoms
时间窗: Throughout study participation at multiple time points, approximately 6 months.
Symptom monitoring before and after LIFU applications and throughout 6 months of follow-up. Each symptom is presented with a likert scale (absent, mild, moderate, severe) - along with a free response option for any symptoms not included in the list.
Changes in Chronic Pain - self report
时间窗: Multiple timepoints throughout the 6 month experimental timeframe.
Participants will complete the Brief Pain Inventory (BPI) at multiple time points throughout the 6 month period. This questionnaire asks participants to rate their pain on a 10 point scale (10 being the most pain).
Changes in Anxiety - self report
时间窗: Throughout the experimental timeframe, approximately 6 months.
Participants will complete the Beck Anxiety Inventory (BAI) at multiple time points before and after LIFU application to track changes in anxiety throughout the 6 month timeframe. The BAI probes different symptoms of anxiety and participants rate it on a likert scale (not at all, mildly, moderately, or severely).
次要结局
未报告次要终点
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University