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MR Guided Focused Ultrasound for Treatment of Neuropathic Pain

NCT03111277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-10-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Focused Ultrasound Foundation

    collaborator OTHER

  • InSightec

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Dheeraj Gandhi · University of Maryland

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2022-10-09
Completion
2022-10-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03111277 on ClinicalTrials.gov