MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04579692|
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : March 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Neuralgia||Device: ExAblate Transcranial treatment||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Thalamotomy of Central Lateral Thalamic Nucleus for the Treatment of Medication-refractory Trigeminal Neuralgia|
|Actual Study Start Date :||February 20, 2021|
|Estimated Primary Completion Date :||November 15, 2023|
|Estimated Study Completion Date :||July 15, 2024|
Experimental: ExAblate Transcranial treatment
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 called central lateral thalamic nucleus. Ultrasound passes through the skin and skull and into the brain to focus on this particular spot.
Device: ExAblate Transcranial treatment
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.
Other Name: The ExAblate® MR guided focused ultrasound system
- Incidence of Treatment related adverse events [ Time Frame: All events will be reported up to 6 months from treatment ]Procedure related or device related adverse events will be reported, from the treatment day through the 6-month follow-up period.
- Change in pain intensity [ Time Frame: 6 months ]Efficacy of ExAblate TcMRgFUS for Thalamotomy will be evaluated using Barrow Neurological Institute (BNI) pain intensity score.
- Change in pain intensity [ Time Frame: 6 months ]Efficacy of ExAblate TcMRgFUS for Thalamotomy will be evaluated using Brief Pain Inventory-Facial.
- Change in pain intensity [ Time Frame: 6 months ]Efficacy of ExAblate TcMRgFUS for Thalamotomy will be evaluated using Pain Numeric rating scale (NRS).
- Change in patient's perception of the effect of the procedure [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579692
|Contact: Dheeraj Gandhi, MD||(248)-email@example.com|
|Contact: Ranyah Almardawi, MBBS/MPHfirstname.lastname@example.org|
|Principal Investigator:||Dheeraj Gandhi, MD||University of Maryland, College Park|