🏛️ Verified NIH Record • Updated 2026-03-18
ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease (NCT03319485)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: InSightec
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (23 items).
Location: Stanford University Medical Center — Stanford, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
- Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.
- Presence of significant cognitive impairment using MMSE ≤ 24.
- Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
- Subjects with an active alcohol or drug dependency or history of drug/alcohol abuse within the past year
- Subjects with unstable cardiac status
- Severe hypertension (diastolic BP \> 100 on medication).
- Current medical condition resulting in abnormal bleeding and/or coagulopathy.
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (20 Sites)
- Stanford University Medical Center — Stanford, California
- Palm Beach Neuroscience Institute/Sperling Medical Group — Boynton Beach, Florida
- University of Maryland Medical System — Baltimore, Maryland
- Brigham and Women's Hospital — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- New York University Health Langone — New York, New York
- Weill Cornell Medicine — New York, New York
- The Ohio State Wexner Medical Center — Columbus, Ohio
- Pennsylvania Hospital Department of Neurosurgery — Philadelphia, Pennsylvania
- University of Virginia Health System — Charlottesville, Virginia
- Swedish Medical Center — Seattle, Washington
- Toronto Western Hospital — Toronto, Ontario
- Rambam Health Care — Haifa,
- Fondazione IRCCS Neurological Institute Carlo Besta — Milan,
- Azienda Ospedaliera Universitaria di Verona, Univerista di Verona — Verona,
- Severance Hospital, Yonsei University Health System — Seoul,
- CINAC-Hospital HM Puerta del Sur — Móstoles, Madrid
- Clinica Universidad De Navarra — Pamplona, Navarre
- Chang Bing Show Chwan Memorial Hospital — Changhua,
- St. Mary's Hospital — London,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.