Open Label Study for the Use of Focused Transcranial Ultrasound for Treatment of Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
A possible treatment approach for neuropathic pain would employ a process designed to promote healthier function of the ventral posteromedial (VPM) and ventral posterolateral (VPL) thalamic nuclei. This study is designed to employ focused ultrasound technology to target the VPM and VPL thalamus among participants with ongoing neuropathic pain syndromes to evaluate for tolerability and early efficacy.
详细描述
The present open-label study is being undertaken to evaluate focused transcranial ultrasound therapy as an intervention for patients with neuropathic pain. The subjects in this research study will be recruited through medical practice. Participants who are enrolled will undergo 8 consecutive weekly ultrasound sessions. Targeting for treatment will be based on patient MRI scans using stereotaxic techniques.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of neuropathic pain (onset, location, intensity, duration, quality, aggravating factors)
- •Confirmation of nervous system injury through imaging or negative or positive sensory signs confined to the corresponding bodily area
- •Failure from at least 3 pharmacological treatments (e.g., antidepressants, anticonvulsants, opioids)
- •At least 18 years of age
排除标准
- •Subjects unable to give informed consent
- •Subjects who would not be able to lay down without excessive movement in a calm environment
- •Pregnancy, women who may become pregnant or are breastfeeding
- •Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Baseline
The NRPS is a unidimensional measure of pain intensity for adults. The 11-point numeric scale ranges from '0' representing 'no pain' to 10 representing 'worst possible pain.' The NPRS can be administered verbally or graphically for self-completion. The respondent is asked to indicate the numeric scale value that best describes the intensity of their pain within the last 24-hours. Clinical improvement is denoted by at least 3 points improvement.
Brief Pain Inventory (BPI)
时间窗: Baseline
Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
Patient Health Questionnaire (PHQ-9)
时间窗: Baseline
The PHQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
次要结局
- Brief Pain Inventory (BPI)(Post Final Treatment (8 weeks from baseline))
- Numeric Pain Rating Scale (NPRS)(Post Final Treatment (8 weeks from baseline))
- Patient Health Questionnaire (PHQ-9)(Post Final Treatment (8 weeks from baseline))