Movement DisordersNCT05539196
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications
An observational study of Movement Disorders and Neurology, run by InSightec at 5 sites in 2 countries.
Trial summary
This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide. Read more about this study
- Who is it for?
- Ages 30 to 99 years
- Conditions the study is for
- Movement Disorders, Neurology, Parkinsons Disease
- What is being tested?
- Exablate Pallidotomy, Unilateral
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 23 Jan 2023to 31 Jul 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population enrolled in this registry will be comprised of male and female patients that plan to be treated using the Exablate Neuro system for advanced, idiopathic Parkinson's disease with medication-refractory moderate to severe motor complications. Subjects must meet the specific eligibility criteria in order to enroll in this Registry.
Who may be able to join
- Men and women, age 30 years and older.
- Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care.
- Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits.
- Subject has signed and received a copy of the approved informed consent form.
Who cannot join
- Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Kaitlyn Henry, 410-328-0939, KHenry@som.umaryland.edu
Howard Eisenberg, MD
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Claire Starcke, 214-645-1568, Charlton.Starcke@UTSouthwestern.edu
Bhavya Shah, MD
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Rachel Olovyannikov, (212) 746-7373, rao4005@med.cornell.edu
Isabella Cipollone, (203) 917-9918, isc4005@med.cornell.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Giovanna Rocchio, 215-829-6720, NPN@uphs.upenn.edu
Casey Halpern, MD
Japan1 site, 1 recruiting
- Recruiting
Ohnishi Neurological Center
Akashi, Hyōgo, 674-0064
Naotaka Satou, +81-78-938-1238, info@onc.akashi.hyogo.jp
Yoshihiro Kuga, MD
About this study
This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.
Read the detailed description
This is a post-approval registry which is required by of the approval under PMA P150038/S014 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral pallidotomy in the treatment of idiopathic Parkinson's Disease with medication-refractory moderate to severe motor complications. Subjects participating in this registry will have received a unilateral pallidotomy using the commercially available Exablate Neuro.
The following assessments will be collected at Baseline, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:
Adverse Events (AEs) (does not apply to Baseline Visit) Medication usage MDS-UPDRS Unified Dyskinesia Rating Scale EQ-5D-5L WPAI-GH Clinician and Patient Global Impression of Change Patient Satisfaction Questionnaire
- Conditions
- Movement Disorders, Neurology, Parkinsons Disease
- Being tested
- Exablate Pallidotomy, Unilateral
- Medical subject headings
- Movement Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate Pallidotomy, UnilateralDevice
Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.
| Study group | Role | What they receive |
|---|---|---|
| Post Exablate Neuro Pallidotomy for Parkinson's Disease with Motor Complications | The population enrolled in this registry will be comprised of male and female patients that plan to be treated using the Exablate Neuro system for advanced, idiopathic Parkinson's disease with medication-refractory moderate to severe motor complications. No intervention is performed under this registry protocol. Receives: Device: Exablate Pallidotomy, Unilateral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Analysis
Primary Effectiveness will be evaluated through a Responder analysis. Responder is defined as the patient reaching a minimally clinically significant difference on: 1) UDysRS Objective Assessment ON Meds, without clinically significant worsening of MDS-UPDRS Part III OFF Meds aggregated extremity score for treated side Or 2) MDS-UPDRS Part III OFF Meds Motor Exam on the treated side, without clinically significant worsening of UDysRS Objective Assessment ON meds
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start23 Jan 2023
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539196
- Sponsor's protocol ID
- PD006PAS/PD015
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes