Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Parkinson Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: This is a bilateral study. Subjects will be treated on one side of the brain and will be allowed to receive treatment on the other side if eligible.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 125 years
- Gender
- Both males and females
Description
This study is a prospective, open label, single-arm, multi-center clinical trial to establish the safety and effectiveness of bilateral PTTractotomy for the treatment of motor complications in patients with bilateral idiopathic Parkinson's Disease. A maximum of 50 subjects will be treated at up to 8...
This study is a prospective, open label, single-arm, multi-center clinical trial to establish the safety and effectiveness of bilateral PTTractotomy for the treatment of motor complications in patients with bilateral idiopathic Parkinson's Disease. A maximum of 50 subjects will be treated at up to 8 sites. Subjects will undergo an Exablate index procedure targeting the PTT and will be seen at 1-week,1-, 3-, and 6- months post treatment. At the 6-month visit, subjects will be evaluated for an Exablate procedure on the other side.
Tracking Information
- NCT #
- NCT04728295
- Collaborators
- Not Provided
- Investigators
- Not Provided
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