A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Pallidotomy in the Treatment of Dyskinesia of Parkinson's Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 8, 2013

Primary Completion Date

May 16, 2017

Study Completion Date

May 16, 2017

Conditions
Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
Interventions
DEVICE

transcranial magnetic resonance guided focused ultrasound pallidotomy

Focused ultrasound is an attractive method for non-invasive thermal ablation of soft tissue, including functional brain targets. Treatment begins by acquiring a series of MR images of the target organ. The physician then identifies a target volume in the MR images, and delineates the treatment contours on the images. Therapy planning software calculates the parameters required to effectively treat the defined target volume. During the treatment, an ultrasound transducer generates a point of focused ultrasound energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, enabling neurophysiological assessment in the low range, and thermal coagulation at higher ranges. MR images acquired during sonication provide a quantitative, real-time temperature map of the target area to confirm the location of the sonication and the size of the affected region.

Trial Locations (1)

120752

Department of Neurosurgery, Yonsei University College of Medicine, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT02003248 - A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Pallidotomy in the Treatment of Dyskinesia of Parkinson's Disease | Biotech Hunter | Biotech Hunter