Phantom Limb Pain, Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury, Spinal Cord Injuries
Conditions
Keywords
neuropathic pain
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.
Interventions
DEVICEExperimental: 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.
Sponsors
Focused Ultrasound Foundation
InSightec
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* These include patients with: 1. Severe uncontrolled neuropathic pain due to radiculopathy or radicular injury 2. Spinal Cord Injury 3. 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: 1. Age greater than 21 and less than 75 years 2. Subjects who are able and willing to give consent and able to attend all study visits, 3. Documented Neuropathic pain for more than 6 months duration, confirmed from clinical history and examination by a pain specialist or neurologist 4. 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 5. Patients with radiculopathy or radicular injury or phantom limb pain should have failed one additional pain intervention such as nerve block, epidural steroid injection, motor cortex or spinal cord stimulator 6. Patients with Spinal cord injury, in addition to having failed a trial of three pain medications, should have failed one additional intervention such as Botox injection or intra-thecal baclofen. 7. Subjects should have been on stable dose of analgesic agents for at least a period of 4 weeks 8. Clinical symptoms consistent with persistent, intractable pain that has remained at average NRS score \>5 for 30 days, significant pain related disability (Pain Disability Index (PDI) score \>30) or severe allodynia. 9. Central lateral thalamotomy is feasible based on evaluation of imaging studies 10. Patient able to communicate sensations during the ExAblate TcMRgFUS treatment 11. Two members of the medical team have agreed upon inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment related adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain measurements using pain numeric rating scale | 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 | 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 |
Countries
United States
Outcome results
None listed