Exablate Ablation for Parkinson's Disease

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

50 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 11 12 13 14}

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

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.

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Unilateral pallidothalamic tractotomy for akinetic-rigid Parkinson's disease: a prospective open-label study. [2023]

2. England 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. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Neurosurgical methods in treatment of Parkinson disease. Current status]. [2019]

4. France pubmed.ncbi.nlm.nih.gov

[Stereotaxic treatment in Parkinson's disease]. [2006]

5. Italy pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2023]

7. United States 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. [2008]

8. United States pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: the Vanderbilt University Medical Center experience, 1998-2004. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Do unilateral ablative lesions of the subthalamic nucleu in parkinsonian patients lead to hemiballism? [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Bilateral Posterior Subthalamic Area Deep Brain Stimulation for Essential Tremor: A Case Series. [2022]

12. Austria pubmed.ncbi.nlm.nih.gov

MRgFUS thalamotomy for the treatment of tremor: evaluation of learning curve and operator's experience impact on the procedural and clinical outcome. [2023]

13. Austria pubmed.ncbi.nlm.nih.gov

Stereotactic robot-assisted MRI-guided laser interstitial thermal therapy thalamotomy for medically intractable Parkinson's disease tremor: technical note and preliminary effects on 2 cases. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Ablative surgery and deep brain stimulation for Parkinson's disease. [2019]