A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

ConditionTremor Associated With Tremor Dominant Parkinson's Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age30-99

SponsorInSightec

About this trial

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

Eligibility criteria

Qualifiers

Men and women, age 30 years and older

Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.

Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits

Subject has signed and received a copy of the approved informed consent form

Disqualifiers

None

Trial design

Treatments tested in this trial

Unilateral thalamotomy

Treatment groups

50 Participants

are divided into 1 treatment group

Sponsors and collaborators

InSightec

Lead sponsor

Source ClinicalTrials.gov