Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04579692
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2020-09-28
Brief Title:
MR Guided Focused Ultrasound FUS for the Treatment of Trigeminal Neuralgia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None