Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS) for Phantom Limb Pain
研究概览
简要总结
The investigators have designed a pragmatic trial of home-based transcranial direct current stimulation (tDCS) for phantom limb pain (PLP), the PLP-EVEREST trial (PLP-EffectiVEness pRagmatic Stimulation Trial) to test a portable device that would reach underrepresented populations and would validate this therapy in a more pragmatic setting. Subjects will be randomized to home-based tDCS of the primary motor cortex (M1) with somatosensory training or usual care only (including their current pharmacological treatments, physical therapy, and occupational therapy). The investigators will therefore test the effectiveness of home-based tDCS and somatosensory training in a real-world, home-based setting. The Investigator will compare patients randomized to this combined strategy vs. usual care alone (subjects from this group will be offered combined treatment at the end of the trial). The investigators hypothesize that the combined strategy will be associated with a significantly larger Cohen's d effect size (at least 1) compared to the control group.
详细描述
The investigators have designed a pragmatic trial of home-based tDCS for PLP, the PLP-EVEREST trial (PLP-EffectiVEness pRagmatic Stimulation Trial) to test a portable device that would reach underrepresented populations and would validate this therapy in a more pragmatic setting. Subjects will be randomized to home-based tDCS of the M1 with somatosensory training or usual care only (including their current pharmacological treatments, physical therapy, and occupational therapy). The investigators will therefore test the effectiveness of home-based tDCS and somatosensory training in a real-world, home-based setting. The investigator will compare patients randomized to this combined strategy vs. usual care alone (subjects from this group will be offered combined treatment at the end of the trial). The investigators hypothesize that the combined strategy will be associated with a significantly larger Cohen's d effect size (at least 1) compared to the control group.
The investigators will perform a pragmatic, parallel randomized clinical trial. Investigators will recruit 290 participants with upper and/or lower bilateral or unilateral limb amputation and phantom limb pain in the chronic phase. All participants will be randomized to receive 20 daily sessions (4 weeks) of active anodal M1 home-based tDCS combined with somatosensory training or usual care. The participants will participate in 23 visits over 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age - older than 18 years
- •Limb amputation
- •Patients who experience PLP regularly (at least once a week)
- •Pain not attributable to other causes, such as peripheral inflammation
- •Current chronic pain as defined by an average pain of at least 4 on the numeric rating scale (NRS, 0: no pain, 10: worst imaginable pain)
排除标准
- •Any clinically significant or unstable medical or psychiatric disorder
- •History of substance abuse in the past 6 months (according to the DSM-V criteria for substance use disorder with six or more symptoms)
- •Uncompensated psychiatric disorder
- •Previous significant neurological history with current significant neurological deficits
- •Previous neurosurgical procedure with craniectomy that would affect current distribution of tDCS
- •Contraindications to tDCS (implanted brain medical devices)
结局指标
主要结局
Visual Analogue Scale (VAS) for Phantom Limb Pain
时间窗: From Baseline to Visit 22 (at 4 weeks)
The VAS is a common assessment that asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). Investigators will use the VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain. This assessment tool is frequently used in many research studies evaluating pain levels in phantom limb.
次要结局
未报告次要终点
研究者
Felipe Fregni, MD, PhD, MPH
Director of Spaulding Neuromodulation Center
Spaulding Rehabilitation Hospital