MR Guided Focused Ultrasound for Treatment of Neuropathic Pain
|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: NCT03111277|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : November 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury Spinal Cord Injuries Phantom Limb Pain||Device: Experimental: ExAblate Transcranial treatment||Not Applicable|
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.
|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 Neuropathic Pain|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: 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. Ultrasound passes through the skin and skull and into the brain to focus on a spot the study investigator wants to treat.
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.
Other Name: The ExAblate® MR guided focused ultrasound system
- Incidence of Treatment related adverse events [ Time Frame: All events will be reported upto 12 months from treatment ]Procedure related or device related adverse events will be reported, from the treatment day through the 12-month follow-up period.
- Change in pain measurements using pain numeric rating scale [ Time Frame: 12 months ]Reduction at 12 months in maximum or average pain scores as measured on Pain numeric rating scale (NRS) by 40% or more without increase in medication consumption by more than 25%.
- Change in pain related disability [ Time Frame: 12 months ]Reduction in Pain related disability by greater than or equal to 30% using pain interference scale on the Brief pain inventory (BPI) at 12-month follow-up
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): NCT03111277
|Contact: Dheeraj Gandhi, MBBS, MD||(248)-email@example.com|
|Contact: Charlene Aldrich, RN, MSNfirstname.lastname@example.org|
|United States, Maryland|
|University of Maryland School of Medicine and University of Maryland Medical Systems||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Charlene Aldrich, RN, MSN 410-804-2316 email@example.com|
|Contact: Charlene Aldrich, RN, BSN 410-328-5332 firstname.lastname@example.org|
|Principal Investigator: Dheeraj Gandhi, MD|
|Principal Investigator:||Dheeraj Gandhi||University of Maryland, College Park|