MR Guided Focused Ultrasound for Treatment of Neuropathic Pain
Condition: Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury; Spinal Cord Injuries; Phantom Limb Pain
MeSH terms: Spinal Cord Injuries; Neuralgia; Radiculopathy; Phantom Limb; Wounds and Injuries
Study type: Interventional

Summary: 
      Neuropathic pain is often a result of direct diseases of peripheral or central nervous system
      with an estimated prevalence of 8% of adults and this pain is associated with significant
      consequences because of longer symptom duration and severity than many of the other pain
      syndromes. Functional brain imaging has revealed that many regions of the brain are engaged
      by painful events, but specific areas such as the thalamus have been markedly implicated.

      The purpose of this study is to determine the feasibility and safety of MRI-guided focused
      ultrasound treatment using the ExAblate Transcranial System in patients suffering from
      Neuropathic pain. This treatment modality offers non-invasive precise treatment potential for
      these patients.
    

Detailed description: 
      The primary purpose of this study is to assess the safety of MRI-guided focused ultrasound
      (MRgFUS) in patients with chronic neuropathic pain whose medicines are not working well. The
      device that will be used to create and send ultrasound waves through the skull is called the
      ExAblate Transcranial system. The ultrasounds waves will precisely target a small part of the
      brain known as the thalamus. Chronic neuropathic pain is a common type of disabling pain that
      affects people.

      Usually, people with chronic neuropathic pain are treated with medicines to control the pain.
      However, these medications may not provide adequate relief of the pain or may be associated
      with undesirable side effects. This study intends to investigate the use of a new technology
      The ExAblate transcranial system for treating patients that are not responding to medications
      and continue to have disabling pain.

      The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be
      causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in
      the brain. The process of ablation is similar to a magnifying glass that uses light to heat a
      small spot on a piece of paper. Ultrasound passes through the skin and skull and into the
      brain to focus on a spot the study investigator wants to treat.Once the spot is destroyed, it
      cannot grow back.
    

Intervention name(s): Experimental: ExAblate Transcranial treatment
Intervention type(s): Device
Intervention description(s): Patients' head will be placed in a device to hold it still for the treatment. Patients will lie headfirst on the ExAblate table. The ExAblate Transcranial helmet will be placed on their head. A device will be placed over their head to hold it and the helmet still. The investigators will measure the study participant's heart, blood pressure, temperature, and breathing rate before the treatment begins. MRI scans will be taken to make sure the ultrasound waves will be aimed exactly within the target. The space between the rubber diaphragm and the helmet will be filled with water. The water will be chilled to avoid heating of the scalp and skull during the ultrasound treatment. A series of MR images will be taken to identify the target area, and plan the study treatment. The study investigators will decide on the area of participant's brain that will be treated. The ExAblate Transcranial system will compute a plan to cover the treatment area.
Other intervention name(s): The ExAblate® MR guided focused ultrasound system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: neuropathic pain