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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks people with advanced Parkinson’s disease whose moderate to severe movement problems are not well controlled by medicine. It follows people getting an Exablate 4000 procedure on one side of the brain as part of their usual care. The study plans to enroll 60 people and follow them for 5 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 30 years old or older.
  • You are scheduled for an Exablate procedure for Parkinson’s movement problems as part of your clinic’s usual care.
  • You are willing to follow the study plan and attend all study visits.
  • You have signed the approved consent form and received a copy.

Who can't join

  • You do not agree to join, or you are unlikely to stay in the study for the full time.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.

Study sites (4)

MD

NY

PA

TX