Boston-Harvard Burn Injury Model System: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Pain Scale
研究概览
简要总结
The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.
If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.
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
- Double (Participant, Outcomes Assessor)
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
- •Providing informed consent to participate in the study
- •Age 18 or older
- •Burn injury with pain and/or itch that is moderate to severe
- •Burn injury occurring at least 3 weeks prior to enrollment
排除标准
- •Subjects with burns in scalp in the area of electrode placement
- •Psychiatric disorders that have led to hospitalization within the past 6 months or signs of suicidality
- •Learning disorders that may prevent patient's ability to complete assessments
- •Unstable conditions preventing travel to study site
- •Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment: carbamazepine, oxcarbazepine, phenytoin
- •Contraindications to tDCS including implanted metal plates in the head or implanted brain medical devices
- •Pregnancy at time of enrollment
- •History of other neurological conditions associated with structural anatomical changes (i.e. stroke, brain injury, Parkinson's)
研究组 & 干预措施
Active tDCS
Subjects will undergo 20 minutes active tDCS.
干预措施: Transcranial direct current stimulation (tDCS) (Device)
Sham tDCS
Subjects will undergo 20 minutes of sham stimulation.
干预措施: Transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
Change in Pain Scale
时间窗: 2 weeks
Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with neuropathic pain due to burn injury, as measured by changes in the Brief Pain Inventory (BPI). Brief Pain Inventory (BPI) consist consists of a 9 part questionnaire. The questions include the severity of pain levels (worst, least, average, \& current), the impact of pain on daily functioning in different areas (mood, walking, relationships, sleep, normal work, \& general activity), current treatments and perceived effectiveness of current treatments. The VAS Pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring patients' worst pain and least pain, on average and at present time.
Change in Itch Severity/Activity Scale
时间窗: 2 weeks
Determine whether anodal transcranial direct current stimulation is effective in reducing itch severity/activity in subjects with neuropathic itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS) .This is a 0 to 10 scale, where 0 indicates no intensity and a 10 indicates unbearable intensity of itching.
次要结局
- Change in Anxiety Scale(2 weeks)
- Change in Depression Scale(2 weeks)
- Change in Post-Traumatic Stress Symptoms Scale(2 weeks)
研究者
Felipe Fregni
Associate Professor
Spaulding Rehabilitation Hospital