Long-Term Safety and Effectiveness Registry of Exablate 4000 Device for Unilateral Thalamotomy in Medication-Resistant Tremor Dominant Parkinsons Disease

What this Trial Is About

Researchers are collecting long-term safety and effectiveness data of unilateral thalamotomy using the Exablate Neuro system for people with medication-refractory tremor dominant Parkinsons Disease TDPD. This observational post-approval registry is required following the approval of the Exablate Model 4000 Type 1.0 and 1.1 devices. The study focuses on patients who have already received this focused ultrasound treatment for tremor associated with TDPD. Participants have undergone unilateral thalamotomy targeting the ventralis medius region using the commercially available Exablate Neuro device. No new interventions are performed during this registry. Data collection includes monitoring medication use and various assessments over time to understand the treatments long-term impact. Participants are followed with assessments at baseline, 1, 3, 6, and 12 months after their procedure, then annually for up to five years. Researchers collect information on adverse events, clinical tremor ratings on medication, Parkinsons motor function, quality of life, and work productivity. The primary outcome is the evaluation of long-term adverse events over five years, alongside measuring tremor and motor symptom impact on disability.

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