Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03111277
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2017-03-27
Brief Title:
MR Guided Focused Ultrasound for Treatment of Neuropathic Pain
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 Neuropathic Pain
Status:
COMPLETED
Status Verified Date:
2022-10
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:
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
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 participants 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 treatOnce the spot is destroyed it cannot grow back
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 participants 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 treatOnce the spot is destroyed it cannot grow back
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