Exablate Ablation for Parkinson's Disease

Not currently recruiting at 8 trial locations

Overseen By Gaganjot Sooch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InSightec

Must be taking: PD medications

Must not be taking: Neuroleptics, Anticoagulants

Disqualifiers: Cognitive impairment, Neurodegenerative diseases, Psychiatric disease, Cardiac issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 6 months

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 5 6}

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

Subject is able to communicate sensations during the Exablate procedure

My Parkinson's disease medication dose has been stable for the last 30 days.

I experience movement issues due to Parkinson's despite taking my medication.

Exclusion Criteria

You show signs of alcohol or drug abuse.

You have a history of abnormal bleeding, blood clotting issues, or certain medical conditions that increase the risk of bleeding. You also have certain health conditions like severe kidney problems, recent seizures, brain tumors, or life-threatening diseases that prevent you from participating in the study. Additionally, if you have certain medical devices in your body or have recently participated in another clinical trial with an active treatment, you may be excluded from this study.

I have been diagnosed with a neurodegenerative disease like Alzheimer's.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo an Exablate index procedure targeting the PTT

6 months

1-week, 1-month, 3-month, and 6-month visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular visits up to 12 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Exablate 4000

Trial Overview The study tests the safety and effectiveness of a staged bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) in treating motor complications in Parkinson's Disease patients. The intervention involves using Exablate 4000 technology with one side treated initially and the second side six months later.

How Is the Trial Designed?

Group I: Exablate Pallidothalamic Tractotomy Experimental Treatment 1 Intervention

Exablate treatment for Advanced Idiopathic Parkinson's Disease

Who Is Running the Clinical Trial?

InSightec

Lead Sponsor

Trials

92

Recruited

3,800+

Dr. Maurice R. Ferré

InSightec

Chief Executive Officer

MD

Dr. Arjun Desai

InSightec

Chief Medical Officer

MD

Published Research Related to This Trial

In a study of 69 patients with advanced Parkinson's disease who underwent deep brain stimulation (DBS), 53% of those with subthalamic nucleus (STN) stimulation reported ongoing adverse events (AEs) four years post-surgery, compared to 35% in the internal globus pallidus (GPi) group.

Most AEs were not severe and affected cognitive, psychiatric, and motor functions, with a notable correlation between the presence of AEs and longer disease duration and pre-existing gait and psychiatric issues in STN DBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter study on deep brain stimulation in Parkinson's disease: an independent assessment of reported adverse events at 4 years. Hariz, MI., Rehncrona, S., Quinn, NP., et al.[2008]

The ExAblate Neuro 4000 system uses Magnetic Resonance guided Focused UltraSound (MRgFUS) to precisely target and thermally ablate specific brain tissues, showing promise particularly in treating conditions like Essential Tremor.

Current clinical applications demonstrate that MRgFUS is both safe and effective, but ongoing advancements in technology are needed to enhance its efficacy and expand its use for various neurological diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of exAblate Neuro 4000, the leading system for brain magnetic resonance guided focused ultrasound technology: an overview of its safety and efficacy in the treatment of medically refractory essential tremor. Jameel, A., Bain, P., Nandi, D., et al.[2021]

The ExAblate device, approved for treating movement disorders like tremor-dominant Parkinson's disease, shows minimal cognitive decline in patients post-treatment, particularly in areas like verbal fluency and inhibition.

Current research on the neurocognitive effects of MRgFUS in Parkinson's disease is limited, with only two studies using comprehensive evaluations, highlighting the need for more rigorous assessments to understand cognitive risks associated with this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound for Parkinson's disease since ExAblate, 2016-2019: a systematic review. Lennon, JC., Hassan, I.[2022]

Deep brain stimulation (DBS) is an effective treatment for Parkinson's disease, allowing patients to reduce their reliance on anti-Parkinson medications and save an average of $2,292 per year after surgery, based on a study of 72 patients.

While DBS is generally safe, the most common adverse event was intracranial hemorrhage occurring in 12.5% of patients, with a small percentage experiencing permanent or transient deficits, indicating that while effective, there are risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: the Vanderbilt University Medical Center experience, 1998-2004. Gill, CE., Konrad, PE., Davis, TL., et al.[2007]

Deep brain stimulation (DBS) is an important treatment option for Parkinson's disease, but estimating the prevalence and categorizing adverse events (AEs) associated with it is challenging due to inconsistent reporting.

The authors advocate for a standardized scheme for reporting AEs related to DBS, which would help in conducting meaningful risk/benefit analyses and assist both physicians and patients in making informed decisions about surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. Videnovic, A., Metman, LV.[2008]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150038S037B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Exablate Neuro is indicated for use in the unilateral pallidothalamic tractotomy of advanced idiopathic Parkinson's Disease with medication- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04728295

Study Details | NCT04728295 | Evaluation of the Safety ... This study is a prospective, open label, single-arm, multi-center clinical trial to establish the safety and effectiveness of bilateral PTTractotomy

3. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P150038S037

Premarket Approval (PMA) - FDA The Exablate Neuro is intended indicated for use in the unilateral pallidothalamic tractotomy of advanced idiopathic Parkinson's Disease with medication ...

4. neurologylive.com neurologylive.com/view/exablate-neuro-gains-fda-approval-staged-bilateral-focused-ultrasound-advanced-pd

Exablate Neuro Gains FDA Approval for Staged Bilateral ... The FDA approved Exablate Neuro for bilateral pallidothalamic tractotomy in advanced Parkinson's disease, enabling comprehensive treatment for ...

5. insightec.com insightec.com/news/insightec-announces-fda-approval-of-staged-bilateral-focused-ultrasound-treatment-for-parkinsons-disease/

Insightec Announces FDA Approval of Staged Bilateral ... ... Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients living with advanced Parkinson's disease (PD).

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150038S037A.pdf

July 8, 2025 InSightec Nadir Alikacem, Ph.D. SVP of Global ... with medication-refractory moderate to severe motor complications as an adjunct to Parkinson's disease medication treatment. The primary safety ...