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Procedure

Focused Ultrasound Pallidotomy for Parkinson's Disease

N/A

Waitlist Available

Research Sponsored by InSightec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment.

Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site

Must not have

Hoehn and Yahr stage in the ON medication state of 3 or greater

Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in udysrs and mds-updrs part iii motor exam score from before treatment to 3 months following treatment

Summary

This trial will test whether a new treatment for Parkinson's disease, focused ultrasound pallidotomy, is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort during the procedure, risk of bleeding due to ultrasound exposure, possible skin burns from MRI components used during treatment, headache or dizziness post-procedure. There might also be risks associated with lying still for an extended period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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I can communicate how I feel during the ExAblate procedure.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have had a seizure in the last year.

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My heart condition is stable.

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My blood pressure is very high even with medication.

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

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I have severe claustrophobia that medication cannot help.

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I need treatment for an intracranial aneurysm or AVM.

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

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I have a brain tumor.

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

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

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I have had deep brain stimulation or specific brain surgery.

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I have kidney disease or am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in udysrs and mds-updrs part iii motor exam score from before treatment to 3 months following treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in udysrs and mds-updrs part iii motor exam score from before treatment to 3 months following treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in udysrs and mds-updrs part iii motor exam score from before treatment to 3 months following treatment for reporting.