Exablate Pallidotomy for Parkinson's Disease

Recruiting at 4 trial locations

Overseen By Gaganjot Sooch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InSightec

Disqualifiers: Non-compliance, others

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

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial observes the effects of a procedure called Exablate Pallidotomy on individuals with advanced Parkinson's disease, particularly those with serious movement problems unresponsive to medication. The trial evaluates the treatment's long-term effectiveness and involves several years of follow-up with participants. Individuals with advanced Parkinson's and challenging movement issues, who are scheduled for the Exablate procedure, may be suitable candidates. Participants must commit to the study's requirements and attend all follow-up visits. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Exablate Pallidotomy?

Research shows that the Exablate Pallidotomy treatment is generally well-tolerated by patients. This treatment uses focused sound waves to target specific brain areas affected by Parkinson's disease. Studies have demonstrated that it can effectively reduce movement-related symptoms.

Importantly, the FDA has approved this treatment for certain Parkinson's patients, indicating a level of safety for its current use. However, like any medical procedure, side effects can occur. Some patients have experienced mild to moderate side effects, but serious issues are rare. The treatment's strong safety record has prompted further study to help as many people as possible.

In summary, while every medical treatment carries some risk, past research and current approvals suggest that Exablate Pallidotomy is a relatively safe option for those with advanced Parkinson's disease. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for advanced Parkinson's disease, which often involve medication like levodopa or surgical interventions like deep brain stimulation, Exablate Pallidotomy offers a non-invasive approach. This treatment uses focused ultrasound waves to precisely target and disrupt problematic brain tissue associated with motor complications. Researchers are excited because this method could provide relief without the risks associated with surgery or the side effects of medication, potentially leading to improved quality of life for patients with severe motor symptoms.

What evidence suggests that Exablate Pallidotomy is effective for Parkinson's disease with motor complications?

Research has shown that the Exablate Neuro system, which uses focused ultrasound, effectively treats movement problems in people with advanced Parkinson's disease. In this trial, participants will undergo a procedure called unilateral pallidotomy, targeting a specific brain area to reduce movement issues in those unresponsive to medication. MRI guidance allows precise targeting of brain areas, enhancing symptom control. The FDA approved this method because it effectively reduces movement symptoms. Overall, this treatment has shown promise for those whose Parkinson's symptoms do not improve with medication. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Inclusion Criteria

Men and women, age 30 years and older.

Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care.

Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline assessments are conducted before the Exablate procedure

1 visit

1 visit (in-person)

Post-Procedure Follow-up

Participants are monitored at 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years

5 years

Visits at 3, 6, 12 months, and annually for 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Exablate Pallidotomy

How Is the Trial Designed?

Group I: Post Exablate Neuro Pallidotomy for Parkinson's Disease with Motor Complications Experimental Treatment 1 Intervention

The population enrolled in this registry will be comprised of male and female patients that plan to be treated using the Exablate Neuro system for advanced, idiopathic Parkinson's disease with medication-refractory moderate to severe motor complications. No intervention is performed under this registry protocol.

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

Citations

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) A summary of the non-clinical studies conducted on the Exablate Neuro can be found in the Summary of Safety and Effectiveness Data. (SSED) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03319485

Study Details | NCT03319485 | ExAblate Pallidotomy for ... The goal of this prospective, two-arm, sham-controlled, randomized, multi-center pivotal study is to evaluate the safety and efficacy of unilateral focused ...

3. 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 uses focused ultrasound to precisely treat targeted areas in the pallidothalamic tract, guided by MRI. The procedure is ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150038S014B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Exablate Neuro is indicated for use in the unilateral pallidotomy of patients with advanced, idiopathic Parkinson's disease with medication-refractory ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2202721

Trial of Globus Pallidus Focused Ultrasound Ablation in ... Unilateral focused ultrasound ablation of the internal segment of globus pallidus has reduced motor symptoms of Parkinson's disease in open-label studies.