Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Changes in the Visual Analog Scale for Phantom Limb Pain
研究概览
简要总结
This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT; active tDCS and sham MT (which consists of using a covered mirror for the therapy); and both sham tDCS and sham MT (covered mirror).
详细描述
Phantom limb pain (PLP) belongs to a group of neuropathic pain syndromes that is characterized by pain in the amputated limb. Rehabilitation for chronic pain involves a structured treatment plan targeting all dimensions of the pain experience, and should include a comprehensive interdisciplinary approach that allows patients to receive the most benefit according to their needs. As in other chronic pain syndromes, chronic Phantom limb pain (PLP) is often difficult to treat; showing to be resistant to classical pharmacological and surgical treatment approaches.
In this context, we hypothesize that novel treatments of PLP need to target specific neural networks associated with this maladaptive plasticity. Transcranial direct current stimulation (tDCS,Soterix ©) is a powerful and non-invasive technique of brain stimulation that is known to significantly modulate plasticity and alleviate chronic pain in various syndromes. device for this trial. This study usiGiven tDCS underlying neural mechanisms, it is critical to use a multimodal approach to treatment - using both tDCS and behavioral therapy simultaneously. In this case, an ideal therapy is mirror therapy (MT).
Recently, we showed that anodal tDCS can induce a selective short-lasting relief from PLP, and repeated applications of anodal tDCS induces long-lasting analgesic effects. These preliminary results show that tDCS may be a promising rehabilitative tool for the management of chronic PLP. This neurorehabilitation technique is commonly used in PLP, and is designed to modulate cortical mechanisms of pain by performing movements using the unaffected limb in front of a mirror. We propose to carry out a mechanistic, factorial, randomized controlled trial to evaluate a novel rehabilitation approach combining tDCS and MT in PLP patients. We aim to compare the brain changes before and after treatment in order to study the mechanisms underlying PLP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, 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
- •Able to provide informed consent to participate in the study.
- •Subject is older than 18 years.
- •Unilateral lower limb amputation.
- •Traumatic amputation greater than 1 year ago.
- •Chronic PLP for at least 3 months previous to enrollment in the study, experienced regularly for at least once a week.
- •Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
- •If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.
排除标准
- •Pregnancy or trying to become pregnant in the next 2 months.
- •History of alcohol or drug abuse within the past 6 months as self-reported.
- •Presence of the following contraindication to transcranial direct current stimulation and transcranial magnetic stimulation
- •Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel)
- •Implanted neck or head electronic medical devices (e.g., cochlear implants, vagus nerve stimulator)
- •History of chronic pain previous to the amputation.
- •Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
- •Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
- •Uncontrolled Epilepsy or prior seizures within the last 1 year.
- •Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).*
- •History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
- •History of neurosurgery, as self-reported.
- •Mirror Therapy in the previous 3 months
结局指标
主要结局
Changes in the Visual Analog Scale for Phantom Limb Pain
时间窗: 4 weeks
The primary endpoint will be the severity of pain measured by changes in PLP from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.
次要结局
- Changes in the Visual Analog Scale for Stump Pain(4 weeks)
- Changes in the Visual Analog Scale for Phantom Limb Sensation(4 weeks)
研究者
Felipe Fregni, MD, PhD, MPH
Principal Investigator
Spaulding Rehabilitation Hospital