The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects. Usually, people with trigeminal pain receive medicines to control the pain. However, these medications may not give adequate pain relief. They may have unwanted side effects. In many patients with Trigeminal Neuralgia, a blood vessel compressing the nerve could be responsible for this condition. In such patients, surgery (also called micro-vascular decompression) is considered to be the best option if the medications do not control the pain. However, not all patients are good candidates for surgical correction and some patients may have recurrence of pain following surgical correction. When surgery is not possible or recommended, other procedures are also available to patients. Such procedures usually result in selective damage to the nerve pain fibers in the Trigeminal nerve. Examples of these treatments include injection of materials such as Glycerol into the nerve, compression of the nerve with a balloon or selective radiation treatment of the nerve (stereotactic Radiosurgery). These treatments may not always improve the patient's pain or may only relieve the pain for a short duration of time. These treatments may also result in damage to the nerve fibers that carry sensation from the face. Our study will assess a new device for treating patients who have disabling pain that has not responded to medications or medications along with surgery. The device we will assess is called the ExAblate Transcranial focused ultrasound system. In this study, we will use this device to send ultrasound waves through the skull to precisely target and treat a tiny area of the brain called central lateral nucleus.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Patients' head will be placed in ExAblate device to hold it still for the treatment. The ExAblate Transcranial helmet will be placed on their head. 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. 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. This area is gradually heated while monitoring the patient's responses and neurologic examination.
University of Maryland Medical Center
Baltimore, Maryland, United States
Incidence of Treatment related adverse events
Procedure related or device related adverse events will be reported, from the treatment day through the 6-month follow-up period.
Time frame: All events will be reported up to 6 months from treatment
Change in pain intensity
Efficacy of ExAblate TcMRgFUS for Thalamotomy will be evaluated using Barrow Neurological Institute (BNI) pain intensity score.
Time frame: 6 months
Change in pain intensity
Efficacy of ExAblate TcMRgFUS for Thalamotomy will be evaluated using Brief Pain Inventory-Facial.
Time frame: 6 months
Change in pain intensity
Efficacy of ExAblate TcMRgFUS for Thalamotomy will be evaluated using Pain Numeric rating scale (NRS).
Time frame: 6 months
Change in patient's perception of the effect of the procedure
Patient Global impression of change (PGIC): The effect of the procedure on patient perceived impact of pain related symptoms, emotions and quality of life will be measured using PGIC scale.
Time frame: 6 months
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