Exablate Ablation for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Exablate 4000 to determine its safety and effectiveness in addressing movement issues caused by Parkinson's disease. The treatment uses focused ultrasound (sound waves) to target specific brain areas affecting movement. Individuals diagnosed with Parkinson's disease, who are on a stable medication regimen, and experience motor complications despite optimal treatment might be suitable candidates for this trial. Participants must also communicate during the procedure and attend all study visits.
As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatment options for Parkinson's disease.
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 prior data suggests that this device is safe for treating Parkinson's Disease?
Research has shown that the Exablate 4000, a device used to assist with movement problems in Parkinson's disease, is generally safe. The FDA approved it for a specific type of brain surgery called pallidothalamic tractotomy, indicating thorough safety checks for other uses as well.
In past studies, patients generally tolerated the Exablate 4000 well. Some side effects were reported, but they were usually mild and temporary. Common side effects might include headaches or dizziness, which often resolve on their own. Anyone considering this treatment should discuss the possible risks and benefits with their doctor.12345Why are researchers excited about this trial?
Unlike the standard Parkinson's treatments such as medication and deep brain stimulation, the Exablate 4000 offers a non-invasive approach using focused ultrasound technology. This treatment targets the pallidothalamic tract, potentially reducing symptoms without the need for surgery or implanted devices. Researchers are excited because it promises fewer side effects and quicker recovery times compared to traditional surgical options, making it a promising alternative for those with advanced idiopathic Parkinson's Disease.
What evidence suggests that Exablate 4000 is effective for Parkinson's Disease?
Research shows that the Exablate 4000 device, used in this trial, assists in a type of brain surgery called pallidothalamic tractotomy to treat movement problems in people with advanced Parkinson's Disease. The FDA has approved this treatment for targeting specific brain areas in Parkinson's patients, indicating its effectiveness. Studies have found that this method can reduce symptoms like tremors and improve movement. This treatment uses focused ultrasound to precisely target parts of the brain responsible for Parkinson's symptoms. While the results are promising, discussing this option with a healthcare provider is important to determine its suitability.12356
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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