Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain (FUS-CLT)
|ClinicalTrials.gov Identifier: NCT01699477|
Recruitment Status : Unknown
Verified October 2012 by University Children's Hospital, Zurich.
Recruitment status was: Recruiting
First Posted : October 3, 2012
Last Update Posted : October 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Functional Brain Disorders /Neuropathic Pain||Device: ExAblate 4000 focused ultrasound brain intervention||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||MR-Guided Functional Ultrasound-Neurosurgery|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
|Trancranial MRg Focused Ultrasound for Neuropatic Pain||
Device: ExAblate 4000 focused ultrasound brain intervention
Non-invasive brain intervention using MR-guided focused ultrasound
- Precision of lesioning [ Time Frame: 3 months ]Comparison of size and location of sonicaion lesions on MRI with planning coordinates.
- Safety measurements [ Time Frame: 6 months ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
- Lesion characteristics [ Time Frame: 3 months ]Size of lesions as a function of applied energy/temperature.
- Clinical Efficacy [ Time Frame: 1 year ]Pain Scores on the Visual Analog Scale following intervention and at follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699477
|Contact: Ernst - Martin, MD||+41 44 266 7111 ext firstname.lastname@example.org|
|Contact: Beat - Werner, MSc||+41 44 266 7111 ext email@example.com|
|MR-Center, University Children's Hospital||Recruiting|
|Zurich, Switzerland, CH-8032|
|Contact: Ernst - Martin, MD +41 44 266 7111 ext 7437 firstname.lastname@example.org|
|Contact: Ronald - Bauer, MD +41 71 494 1111 ext 3054 email@example.com|
|Principal Investigator: Ernst - Martin, MD|
|Sub-Investigator: Beat - Werner, MSc|
|Principal Investigator:||Ernst - Martin, MD||University Children's Hospital, Zurich|
|Principal Investigator:||Ronald - Bauer, MD||Neurosurgery, Kantonsspital St. Gallen, Switzerland|
|Principal Investigator:||Gunther - Landmann, MD||Center for Pain Medicine, Nottwil, Switzerland|