NCT04728295

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD).

Detailed 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 10 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Exablate 4000	Exablate Pallidothalamic Tractotomy

Timeline

• Start date: 2021-05-14
• Primary completion: 2024-03-28
• Completion: 2028-12-01
• First posted: 2021-01-28
• Last updated: 2025-02-17

Locations

9 sites across 3 countries: United States, Spain, Taiwan

Regulatory

• FDA-regulated device study