Focused Ultrasound Pallidotomy for Parkinson's Disease

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: InSightec

No Placebo Group

Trial Summary

What is the purpose of this trial?Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.

Eligibility Criteria

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

My Parkinson's disease symptoms are severe without medication or I have complications despite treatment.

I have been diagnosed with Parkinson's disease by a specialist.

My Parkinson's symptoms are severe without medication or I have complications despite treatment.

I can communicate how I feel during the ExAblate procedure.

My Parkinson's symptoms improve by at least 30% when I take my medication.

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.

I have had a seizure in the last year.

My heart condition is stable.

My blood pressure is very high even with medication.

I cannot or do not want to stay lying down for a long time.

I have severe claustrophobia that medication cannot help.

I need treatment for an intracranial aneurysm or AVM.

I think my Parkinson-like symptoms might be due to my medication.

I have a brain tumor.

I have had a brain bleed, multiple strokes, or a stroke in the last 6 months.

I do not have uncontrolled mental health issues like severe depression or hallucinations.

I have had deep brain stimulation or specific brain surgery.

I have kidney disease or am on dialysis.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExAblate PallidotomyExperimental Treatment1 Intervention

ExAblate treatment for Advanced Idiopathic Parkinson's Disease

Group II: Sham ExAblate PallidotomyPlacebo Group1 Intervention

Sham (fake) treatment