NCT03111277

MR Guided Focused Ultrasound for Treatment of Neuropathic Pain

Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Thalamotomy of Central Lateral Thalamic Nucleus for the Treatment of Neuropathic Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury
• Spinal Cord Injuries
• Phantom Limb Pain

Interventions

Type	Name	Description
DEVICE	Experimental: ExAblate Transcranial treatment	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.

Timeline

• Start date: 2017-09-15
• Primary completion: 2022-10-09
• Completion: 2022-10-09
• First posted: 2017-04-12
• Last updated: 2022-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study