Trials / Completed
CompletedNCT03964272
A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD
A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- InSightec · Industry
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features
Detailed description
The objective of this study is to evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) bilateral staged subthalamotomy for the treatment of PD motor features. To determine the effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy to treat cardinal motor features of subjects with PD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Exablate Bilateral Subthalamotomy | Exablate bilateral treatment for Parkinson's Disease Motor Features |
Timeline
- Start date
- 2019-06-18
- Primary completion
- 2023-11-07
- Completion
- 2023-11-07
- First posted
- 2019-05-28
- Last updated
- 2026-03-20
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03964272. Inclusion in this directory is not an endorsement.