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Subthalamotomy by ExAblate Transcranial System to Treat Motor Features of Parkinson's Disease

NCT02912871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-01-31

No results posted yet for this study

Summary

Based on published animal and human studies, ExAblate Transcranial subthalamotomy can be as safe and as effective as any of the surgical treatments within the currently accepted standard of care including radiofrequency lesioning and Deep Brain Stimulation (DBS). A unilateral lesion of the subthalamic nucleus has shown reduction of contralateral motor symptoms in Parkinson's disease (PD). Using ExAblate Transcranial Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) to create the subthalamotomy has several potential advantages over current therapies including the fact that transcranial lesioning can be performed in a precise manner with simultaneous as well as continuous clinical and radiographic monitoring. If the potential of ExAblate Transcranial subthalamotomy can be realized, it could supplant radiofrequency and radiosurgery techniques and provide a viable alternative procedure for subjects considering DBS.

Conditions

Interventions

OTHER

MRIgHIFU unilateral subthalamotomy

High Intensity focused ultrasound unilateral subthalamotomy: Unilateral thermolesion in the Subthalamic nucleus performed by High Intensity Focused ultrasound

Sponsors & Collaborators

  • Insightech

    collaborator UNKNOWN

  • Fundación de investigación HM

    lead OTHER

Principal Investigators

  • Jose Obeso, MD, PhD · CINAC, HM Puerta del Sur. Avda. Carlos V nº 70. CP 28938. Móstoles MADRID (SPAIN) Tel: +34 91 2673201; Email: [email protected]

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-01-31
Completion
2017-01-31

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Entities

Diseases

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 NCT02912871 on ClinicalTrials.gov