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Exablate 4000 for Parkinson's Disease Motor Complications Registry

This study is a registry for people with advanced Parkinson's Disease who have motor complications (movement problems) that are not well-controlled by medication. It is observing the effects of a treatment called Exablate Pallidotomy, Unilateral, which uses focused ultrasound. You may be able to join if you are 30 years or older and are already planning to have this Exablate procedure for your Parkinson's Disease. The main goal is to see how people respond to the treatment over 5 years. The study is currently unclear about its recruitment status.

Study design
This is an observational registry that will follow 60 participants at about 10 centers worldwide. It is a single-arm study, meaning all participants receive the same intervention.
What's involved
You would have assessments at baseline, 3, 6, and 12 months after the Exablate procedure, and then annually for 5 years. These assessments include checking for side effects, medication use, and various scales to measure your symptoms and quality of life.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05539196

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

Recruiting
Not specifiedAges 30–99Observational
InSightec
~60 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Exablate Pallidotomy, Unilateral

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Responder Analysis
Measured over 5 years

Conditions

Movement Disorders
Neurology
Parkinsons Disease

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Parkinson Disease

NCT05539196

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ohnishi Neurological Center

    Akashi, Hyōgo, Japanstudy coordinator listed

    Recruiting

  • University of Maryland, Baltimore

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Weill Cornell Medicine

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Kingsley Nwaogu
[email protected]
2143048265
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.

What this trial measures

  • Responder Analysis5 years

    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