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Researchers are collecting long-term safety and effectiveness data on using the Exablate Neuro system for unilateral thalamotomy to treat medication-refractory tremor dominant Parkinson's Disease (TDPD). This post-approval registry is conducted under regulatory approval to monitor outcomes in patients who have undergone the procedure for essential tremor and TDPD. The study involves patients who have already received a unilateral thalamotomy targeting the ventralis medius area using the commercially available Exablate Neuro Model 4000 Type 1.0 or 1.1 device. The treatment uses focused ultrasound technology to address tremors that do not respond to medication. Participants will be followed for five years with assessments at baseline, 1, 3, 6, and 12 months after the procedure, and then annually. Researchers will collect data on adverse events, medication use, tremor severity using the Clinical Rating Scale for Tremor, Parkinson's motor symptoms via the Unified Parkinson's Disease Rating Scale Part III, quality of life with EQ-5D-5L, and work productivity through WPAI-GH questionnaires to monitor safety and treatment impact over time.

Age: 30Years - 99YearsAll Genders
8 locations