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

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

This trial does not accept healthy volunteers

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 population

The patient population enrolled in this registry will be comprised of male and female patients that plan to be treated for TDPD using the Exablate Neuro system.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Unilateral thalamotomy

    Device

    Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease1 intervention

Trial outcomes

Primary outcomes

1

Long-term adverse events.

This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system.

Time frame
Five years.

Secondary outcomes

1

Tremor/motor intensity and impact on disability

Long term tremor motor scores and the impact of tremor on disability will be monitored using components of the Clinical Rating Scale for Tremor (CRST)

Time frame
Five years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.