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

Conditions

• Tremor Associated With Tremor Dominant Parkinson's Disease

Eligibility Criteria

Sex

ALL

Age

30 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 28, 2022

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease
  This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol.

Primary Outcome Measure

Long-term adverse events. [ Time Frame: Five years. ]

Central Contacts

• Matt Hibert
  214-630-2000
  [email protected]

Locations (7)

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