Exablate Ablation for Parkinson's Disease
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants be on a stable dose of all Parkinson's Disease medications for 30 days before the screening visit. However, if you are taking anticoagulant or antiplatelet medications, you must stop them within one week of the procedure.
What data supports the effectiveness of the Exablate 4000 treatment for Parkinson's disease?
The Exablate 4000 system, which uses focused ultrasound to target specific brain areas, has been approved for treating movement disorders like tremor-dominant Parkinson's disease and essential tremor. Studies have shown it to be effective in reducing symptoms without the need for incisions, offering a promising alternative to other surgical methods.12345
Is Exablate Ablation generally safe for humans?
Exablate Ablation, also known as Exablate 4000, has been evaluated for safety in humans, showing that it can be performed safely with rare and mostly mild adverse effects. In a study of nine patients with Parkinson's disease, only one experienced temporary involuntary movements, which improved within two weeks, and no long-term adverse effects were observed.678910
How is the Exablate 4000 treatment different from other treatments for Parkinson's disease?
Exablate 4000 is a non-invasive treatment that uses focused ultrasound waves to target and destroy specific brain tissue, which is different from traditional surgical methods or deep brain stimulation that require incisions or implants. This approach offers a less invasive option for patients with Parkinson's disease who may not be suitable for other surgical treatments.111121314
What is the purpose of this trial?
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).
Eligibility Criteria
This trial is for men and women aged 30 or older with Parkinson's Disease who want a bilateral treatment option, can give informed consent, attend all visits, are on stable PD medication doses for 30 days prior to screening, can communicate during the procedure, and have motor complications despite optimal medical treatment. Exclusions include pregnant/lactating women, substance abuse behaviors, other neurodegenerative diseases or significant cognitive impairment, unstable psychiatric disease or cardiac status, bleeding risks including low platelets/coagulopathy/stroke history/anticoagulant use within specific timeframes before the procedure.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects undergo an Exablate index procedure targeting the PTT
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Exablate 4000
Find a Clinic Near You
Who Is Running the Clinical Trial?
InSightec
Lead Sponsor
Dr. Maurice R. Ferré
InSightec
Chief Executive Officer
MD
Dr. Arjun Desai
InSightec
Chief Medical Officer
MD