Focused Ultrasound Pallidotomy for Parkinson's Disease

Not currently recruiting at 20 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InSightec

Must be taking: Levodopa, Antidepressants

Must not be taking: Anticoagulants, Antiplatelets

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

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using focused ultrasound, called ExAblate Pallidotomy, to help manage symptoms in people with advanced Parkinson's disease. The researchers aim to determine if this method can safely reduce movement issues like dyskinesia (uncontrolled movements) in patients who do not respond well to medication. The trial includes a real treatment group and a sham (fake) treatment group for comparison. Ideal participants are those diagnosed with Parkinson's disease who still experience motor issues despite taking medication. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

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

The trial requires that you stay on a stable dose of all Parkinson's disease medications for 30 days before joining. If you're on antidepressants, they should be stable for at least 3 months. However, you must stop taking anticoagulants (blood thinners) like warfarin or antiplatelet drugs like aspirin one week before the procedure.

What prior data suggests that the ExAblate 4000 System is safe for managing Parkinson's disease?

Research shows that ExAblate Pallidotomy, a focused ultrasound treatment, has been tested for safety in people with advanced Parkinson's disease. This treatment uses sound waves to target specific areas of the brain. Studies have found that it can reduce movement problems without requiring surgery.

The FDA has already approved the ExAblate system for treating essential tremor, indicating that its safety is well-understood for similar uses. In past studies, patients tolerated the treatment well and experienced fewer symptoms. Some side effects, such as temporary headaches or dizziness, were reported, but these were usually mild and short-lived.

While more research is needed to confirm long-term safety, early results suggest that ExAblate Pallidotomy could be a promising option for people with Parkinson's who haven't found relief from medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for Parkinson's disease, which often involve medication or surgical procedures like deep brain stimulation, ExAblate Pallidotomy uses focused ultrasound to target and destroy specific brain tissue without any incisions. This non-invasive technique offers a unique advantage by reducing the risks associated with surgery, such as infection or bleeding. Researchers are particularly excited about this approach because it promises quicker recovery times and may provide significant symptom relief for patients with advanced Parkinson's disease, all without the need for hospitalization or anesthesia.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

Research shows that focused ultrasound pallidotomy, using the ExAblate 4000 System, can reduce movement problems in people with advanced Parkinson's disease. Studies have found that it lessens dyskinesia, the uncontrolled movements often seen in this condition. One major study showed that this treatment improved movement in patients who did not respond well to medication. Participants in this trial may receive the ExAblate Pallidotomy treatment. Additionally, the ExAblate Neuro device has been approved for similar treatments, supporting its safety and effectiveness. These findings provide strong evidence for considering this treatment option. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for men and women over 30 with advanced Parkinson's disease who have not responded well to medications. Participants must be diagnosed by specific criteria, respond to Levodopa, and be on stable medication doses. They cannot have severe cognitive impairment or other neurodegenerative diseases, a history of certain brain procedures, uncontrolled blood pressure or bleeding disorders, kidney issues, MR contraindications like severe claustrophobia or weight limits.

Inclusion Criteria

I have been on the same antidepressant for at least 3 months.

You can tell how you are feeling during the procedure.

Subjects who are able and willing to give informed consent and able to attend all study visits through 12 Months

Exclusion Criteria

My Parkinson's disease is advanced, affecting my physical movements even with medication.

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

I have a condition that causes abnormal bleeding or blood clotting issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive unilateral focused ultrasound pallidotomy using the ExAblate 4000 System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ExAblate Pallidotomy
• Sham ExAblate Pallidotomy

Trial Overview The study tests the safety and effectiveness of ExAblate Pallidotomy—a focused ultrasound procedure—against a sham (fake) version for managing dyskinesia symptoms in Parkinson's patients. It involves one group receiving the real treatment while another receives a non-therapeutic procedure to compare outcomes.

How Is the Trial Designed?

Group I: ExAblate Pallidotomy Experimental Treatment 1 Intervention

ExAblate treatment for Advanced Idiopathic Parkinson's Disease

Group II: Sham ExAblate Pallidotomy Placebo Group 1 Intervention

Sham (fake) treatment

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03319485

Study Details | NCT03319485 | ExAblate Pallidotomy for ... Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or ...

2. 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.

3. 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- ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30095337/

The efficacy and limits of magnetic resonance-guided ... The efficacy and limits of magnetic resonance-guided focused ultrasound pallidotomy for Parkinson's disease: a Phase I clinical trial · Authors.

5. fusfoundation.org fusfoundation.org/posts/pivotal-trial-results-of-focused-ultrasound-for-parkinsons-disease-published-in-the-new-england-journal-of-medicine/

Pivotal Trial Results of Focused Ultrasound for Parkinson's ... Results from a multicenter, international clinical trial of focused ultrasound to address the major motor symptoms of Parkinson's disease (PD) ...

6. 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 ... The Exablate Neuro platform previously received FDA approval for unilateral treatment of medication-refractory essential tremor in 2016, tremor- ...