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Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain

NCT01699477 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-10-03

No results posted yet for this study

Summary

The aim of this study is to asses the efficacy and the clinical safety of the transcranial magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec Ltd. for functional neurosurgery. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology and will serve as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.

Conditions

  • Functional Brain Disorders /Neuropathic Pain

Interventions

DEVICE

ExAblate 4000 focused ultrasound brain intervention

Non-invasive brain intervention using MR-guided focused ultrasound

Sponsors & Collaborators

  • University Children's Hospital, Zurich

    lead OTHER

Principal Investigators

  • Ernst - Martin, MD · University Children's Hospital, Zurich

  • Ronald - Bauer, MD · Neurosurgery, Kantonsspital St. Gallen, Switzerland

  • Gunther - Landmann, MD · Center for Pain Medicine, Nottwil, Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Switzerland

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 NCT01699477 on ClinicalTrials.gov