NCT04692116

Parkinson's Disease (PD) Treated With Focused Ultrasound Subthalamotomy at an Early Stage

EarlyFocus I: A Single Center Study on the Short-term Safety of Parkinson's Disease (PD) Treated With Focused Ultrasound Subthalamotomy at an Early Stage (<5 Years From the Diagnosis).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Fundación de investigación HM · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Parkinson's disease (PD) is a common, progressive, incurable neurodegenerative disease that can result in severe disability and impairment in health-related quality of life. Current medical and surgical therapies are aimed toward maximal symptom relief with minimal associated side effects or morbidity. It is generally accepted that a well-placed stereotactic lesion is comparable in its magnitude of clinical effect to the high frequency electrical stimulation of the same target. Exablate Neuro is intended to treat movement disorders with unilateral ablation of targets in the thalamus, subthalamic nucleus and globus pallidus nuclei. With the ExAblate system, transcranial high-intensity focused ultrasound has been coupled with high resolution MRI to provide precise, consistent treatments that can be monitored throughout the procedures.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	ExAblate treatment	Subthalamotomy using the ExAblate

Timeline

• Start date: 2020-11-25
• Primary completion: 2021-11-12
• Completion: 2021-11-12
• First posted: 2020-12-31
• Last updated: 2022-06-07

Locations

1 site across 1 country: Spain