Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Thalamotomy of Central Lateral Thalamic Nucleus for the Treatment of Neuropathic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment related adverse events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
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 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.
Investigators
Dheeraj Gandhi
Professor of Radiology, Neurology and Neurosurgery
University of Maryland, Baltimore
Eligibility Criteria
Inclusion Criteria
- •These include patients with:
- •Severe uncontrolled neuropathic pain due to radiculopathy or radicular injury
- •Spinal Cord Injury
- •Phantom Limb Pain
- •Patients that have had prior motor cortex stimulation or spinal cord stimulators will be eligible provided that the hardware has been removed at least six months ago. Detailed inclusion and exclusion criteria for the study are listed below:
- •Inclusion criteria:
- •Age greater than 21 and less than 75 years
- •Subjects who are able and willing to give consent and able to attend all study visits,
- •Documented Neuropathic pain for more than 6 months duration, confirmed from clinical history and examination by a pain specialist or neurologist
- •Failure to respond to any of the usual therapeutic regimens considered to be standard of care for neuropathic pain. The patient should have failed a trial of at least three pain medications, including at least one opioid agent
Exclusion Criteria
- •Patient with contra-indications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
- •Severe psychiatric disorder such as uncontrolled depression, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
- •Life expectancy less than 12 months
- •Anticoagulant or antiplatelet medications as well as underlying coagulopathy
- •Prior or currently implanted thalamic DBS
- •Pregnant ladies or women of childbearing age who are sexually active and not using contraception
- •Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
- •Presence of intracranial mass or an acute intracranial abnormality
- •Subjects with unstable cardiac status such as Unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry and ejection fraction less than 40
- •Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in pain measurements using pain numeric rating scale(12 months)
- Change in pain related disability(12 months)