MR Guided Focused Ultrasound for Treatment of Neuropathic Pain

NCT03111277 | Completed DMC FDA Device

• 1 other identifier: HP-00068223
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury; Spinal Cord Injuries; Phantom Limb Pain

Keywords

neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment related adverse events

  Procedure related or device related adverse events will be reported, from the treatment day through the 12-month follow-up period.

  All events will be reported upto 12 months from treatment

Secondary Outcomes (2)

• Change in pain measurements using pain numeric rating scale

  12 months

• Change in pain related disability

  12 months

Study Arms (1)

Experimental: ExAblate Transcranial treatment

EXPERIMENTAL

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

Interventions

Experimental: ExAblate Transcranial treatment DEVICE

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.

Also known as: The ExAblate® MR guided focused ultrasound system

Experimental: ExAblate Transcranial treatment

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• These include patients with:
• Severe uncontrolled neuropathic pain due to radiculopathy or radicular injury
• Spinal Cord Injury
• Phantom Limb Pain

You may not qualify if:

• 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
• 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
• 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.
• Subjects should have been on stable dose of analgesic agents for at least a period of 4 weeks
• 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.
• Central lateral thalamotomy is feasible based on evaluation of imaging studies
• Patient able to communicate sensations during the ExAblate TcMRgFUS treatment
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Focused Ultrasound Foundation: collaborator
• InSightec: collaborator

Study Sites (1)

University of Maryland School of Medicine and University of Maryland Medical Systems

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Ahmed AK, Zhuo J, Gullapalli RP, Jiang L, Keaser ML, Greenspan JD, Chen C, Miller TR, Melhem ER, Sansur CA, Eisenberg HM, Gandhi D. Focused Ultrasound Central Lateral Thalamotomy for the Treatment of Refractory Neuropathic Pain: Phase I Trial. Neurosurgery. 2024 Apr 1;94(4):690-699. doi: 10.1227/neu.0000000000002752. Epub 2023 Nov 10.

  PMID: 37947407 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Phantom Limb; Neuralgia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Dheeraj Gandhi

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology, Neurology and Neurosurgery

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 12, 2017
• Study Start: September 15, 2017
• Primary Completion: October 9, 2022
• Study Completion: October 9, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)