Clinical Trial: Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)

Brief Summary: This study 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).

Detailed Summary:

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
Sponsor: Spaulding Rehabilitation Hospital

Current Primary Outcome: Changes in the Visual Analog Scale for Phantom Limb Pain [ Time Frame: Measured for approximately 13-14 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Changes in the Visual Analog Scale for Phantom Limb Stump Pain [ Time Frame: Measured for approximately 13-14 weeks ]
  The end point will be severity of pain measured by changes in PLP as indexed by a Visual Analog Scale (VAS).
• Changes in the Visual Analog Scale for Phantom Limb Sensation [ Time Frame: Measured for approximately 13-14 weeks ]
  The end point will be severity of pain measured by changes in PLP as indexed by a Visual Analog Scale (VAS).
• Changes in the Visual Analog Scale for Phantom Limb telescoping [ Time Frame: Measured for approximately 13-14 weeks ]
  The end point will be severity of pain measured by changes in PLP as indexed by a Visual Analog Scale (VAS).
• Adapted Groningen Questionnaire after Arm Amputation [ Time Frame: Baseline (first visit after screening; usually will occur approximately within 1 week from enrollment) ]
  This questionnaire is originally meant to obtain information's concerning complaints that may be developed after arm amputation. We adapted the current arm version for lower limb amputation. This questionnaire has been used in several clinical trials assessing PLP.
• Pain and medication diary [ Time Frame: Measured for approximately 13-14 weeks ]
  To help monitor pain levels and medication use information, as well as safety. Subjects will be asked to record the number of phantom limb episodes on a daily basis, using a pain diary. They will record the intensity of the strongest episode as well as phantom limb sensation and stump pain on a colored visual analog scale included in the diary, where 0 represents no pain at all and 10 represents the highest pain the patient has ever felt. Moreover subjects will record their current medications and dosages daily in a pain medication diary, until completion of the study.
• Beck depression Inventory [ Time Frame: Screening (first study visit; usually done same day as enrollment) and follow-ups (~3-4, ~5-6, ~ 9-10, and ~13-15 weeks after enrollment) ]
  This self-report inventory consists of 21 multiple-choice questions and is widely used method to classify depression severity. It assesses for the presence of several symptoms related to depression, such as irritability, hopelessness and decreased cognitive performance. Physical symptoms such as weight loss and fatigue are also included. This instrument has been used previously to evaluate depression severity in patients with phantom limb pain, as well as in other chronic pain conditions.
• Beck anxiety Inventory [ Time Frame: Baseline (approximately within 1 week from enrollment) and follow-ups (~3-4, ~5-6, ~ 9-10, and ~13-15 weeks after enrollment) ]
  This self-report inventory consists of 21 multiple-choice questions about how the subject has been feeling in the last week, expressed as common symptoms of anxiety (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). It is designed for an age range of 17-80 years old. Each question has the same set of four possible answer choices, which are arranged in columns and are answered by marking the appropriate one with a cross.
• Mini Mental State examination (MMSE) [ Time Frame: Baseline (approximately within 1 week from enrollment) ]
  This is a sensitive, valid and reliable 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. This instrument will be used as a brief screening of cognitive abilities. It will be used as a baseline evaluation
• Quality of Life Assessment (Short version of SF-36) [ Time Frame: Baseline (approximately within 1 week from enrollment) and some follow-ups (~5-6 weeks and ~13-14 weeks after enrollment) ]
  The short version of the SF-36 health survey is used as a measurement of quality of life. It provides a profile of functional health and well-being scores. It is also used as a psychometrical index of physical and mental health. This instrument is widely used as a quality of life assessment in patients after an amputation and those suffering from phantom limb pain.
• Stroop test [ Time Frame: Baseline (approximately within 1 week from enrollment) and some follow-ups (~3-4, ~5-6, and ~13-14 weeks after enrollment) ]
  In this task the subject is presented with names of colors written in the same color or in a different color, thus on the one hand the word names a color (red) and is written in another color (blue). In this task, the automatized behavior (reading) is in conflict with the desired response (naming the color). The Subject has to inhibit/suppress the automatic response of reading and naming the color the word is written in. The Stroop is one of the most commonly used tools for determining attentional problems, also used to assess executive function and working memory. Stroop test will be applied as a preliminary safety assessment of cognitive changes from baseline to post and follow-up visits.
• Side Effects Q
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Spaulding Rehabilitation Hospital
  

  Dates:
  Date Received: June 22, 2015
  Date Started: July 2015
  Date Completion: July 2019
  Last Updated: March 17, 2017
  Last Verified: March 2017