ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
NCT ID: NCT03319485
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
92 participants
INTERVENTIONAL
2018-02-09
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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ExAblate Pallidotomy
ExAblate treatment for Advanced Idiopathic Parkinson's Disease
ExAblate Pallidotomy
ExAblate Pallidotomy for Parkinson's Disease
Sham ExAblate Pallidotomy
Sham (fake) treatment
Sham ExAblate Pallidotomy
ExAblate MRgFUS Sham Procedure
Interventions
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ExAblate Pallidotomy
ExAblate Pallidotomy for Parkinson's Disease
Sham ExAblate Pallidotomy
ExAblate MRgFUS Sham Procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects who are able and willing to give informed consent and able to attend all study visits through 12 Months.
3. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
4. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
5. MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment .
6. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry as determined by medical records.
7. Subject is able to communicate sensations during the ExAblate procedure.
8. Subjects on stable antidepressant medications for at least 3 months
Exclusion Criteria
2. 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.
3. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
4. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.
5. Presence of significant cognitive impairment using MMSE ≤ 24.
6. Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
7. Subjects with an active alcohol or drug dependency or history of drug/alcohol abuse within the past year
8. Subjects with unstable cardiac status
9. Severe hypertension (diastolic BP \> 100 on medication).
10. Current medical condition resulting in abnormal bleeding and/or coagulopathy.
11. Receiving anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g., Avastin) within one month of focused ultrasound procedure.
12. Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter; a documented clinical coagulopathy; or INR coagulation studies exceeding the institution's laboratory standard
13. Patient with kidney disease or on dialysis.
14. Subjects with standard contraindications for MR imaging
15. Significant claustrophobia that cannot be managed with mild medication.
16. Subjects who weigh more than the upper weight limit of the MR scanner table and who cannot fit into the MR scanner.
17. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
18. History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months.
19. Subjects with a history of seizures within the past year.
20. Subjects with brain tumors.
21. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
22. Are participating or have participated in another clinical trial in the last 30 days.
30 Years
ALL
No
Sponsors
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InSightec
INDUSTRY
Responsible Party
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Locations
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Stanford University Medical Center
Stanford, California, United States
Palm Beach Neuroscience Institute/Sperling Medical Group
Boynton Beach, Florida, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
New York University Health Langone
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
The Ohio State Wexner Medical Center
Columbus, Ohio, United States
Pennsylvania Hospital Department of Neurosurgery
Philadelphia, Pennsylvania, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Toronto Western Hospital
Toronto, Ontario, Canada
Rambam Health Care
Haifa, , Israel
Fondazione IRCCS Neurological Institute Carlo Besta
Milan, , Italy
Azienda Ospedaliera Universitaria di Verona, Univerista di Verona
Verona, , Italy
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
CINAC-Hospital HM Puerta del Sur
Móstoles, Madrid, Spain
Clinica Universidad De Navarra
Pamplona, Navarre, Spain
Chang Bing Show Chwan Memorial Hospital
Changhua, , Taiwan
St. Mary's Hospital
London, , United Kingdom
Countries
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References
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Krishna V, Fishman PS, Eisenberg HM, Kaplitt M, Baltuch G, Chang JW, Chang WC, Martinez Fernandez R, Del Alamo M, Halpern CH, Ghanouni P, Eleopra R, Cosgrove R, Guridi J, Gwinn R, Khemani P, Lozano AM, McDannold N, Fasano A, Constantinescu M, Schlesinger I, Dalvi A, Elias WJ. Trial of Globus Pallidus Focused Ultrasound Ablation in Parkinson's Disease. N Engl J Med. 2023 Feb 23;388(8):683-693. doi: 10.1056/NEJMoa2202721.
Other Identifiers
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PD006
Identifier Type: -
Identifier Source: org_study_id
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