NCT03964272Completed
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
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 23 May 2019
- Start date
- 18 Jun 2019
- Primary completion date
- 7 Nov 2023
- Lead sponsor
- InSightec
- Diseases
- Parkinson disease
- NCT number
- NCT03964272
What you commit to
- Study type: Interventional
- Participants enrolled: 6
- From 18 Jun 2019 to the primary completion date, 7 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hoehn and Yahr stage in the ON medication state of 2.5 or greater
- Parkinsonian symptoms are a side effect from neuroleptic medications
- History of a bleeding disorder or receiving anticoagulant
Other illness
- Presence of other central neurodegenerative disease
- Subjects with advanced kidney disease or on dialysis
- Subjects with known intolerance or allergies to the MRI contrast agents.
- History of multiple strokes, or a stroke within past 6 months
- Subjects with a history of seizures within the past year
- Subjects with malignant brain tumors
Other
- Presence of severe dyskinesia as noted by MDS-UPDRS scores
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
- Presence of unknown or MRI unsafe devices anywhere in the body.
- Women who are pregnant or nursing
Who the study is looking for
- Male or Female age 30 years or older
- Able and willing to give consent and able to attend all study visits
- A confirmed diagnosis of Parkinsons Disease
- Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms
- Able to localize subthalamic nucleus on MRI for treatment
- Able to communicate sensations during the ExAblate MRgFUS procedure
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario HM Puerta Del Sur. CINAC Coordinator of this site? Confirm its status | Móstoles | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.