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Active, not recruiting Not applicable

ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease

NCT03319485 · tracked via the Priya Life Science UK tracker
Sponsor
Phase
Not applicable
Started
2018-02-09
Last updated
2026-03-20

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

ExAblate PallidotomySham ExAblate Pallidotomy

ExAblate Pallidotomy: ExAblate Pallidotomy for Parkinson's Disease

Sham ExAblate Pallidotomy: ExAblate MRgFUS Sham Procedure

Study summary

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

Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Men and women, age 30 years and older. 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: 1. Hoehn and Yahr stage in the ON medication state of 3 or greater. 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.

Primary outcome measure(s)

  • Responder Analysis — Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment
    Responder is defined as the patient reaching a minimally clinically significant difference on: 1. UDysRS (this measures dyskinesia and their impact) OR 2. MDS-UPDRS Part III Motor Exam -Total score (this measures overall motor fluctuations).

Trial sites (20)

FacilityCityRegionStatus
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 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
Clinica Universidad De Navarra Pamplona Navarre
Chang Bing Show Chwan Memorial Hospital Changhua Taiwan
St. Mary's Hospital London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03319485 on ClinicalTrials.gov ↗ ← All trials in the UK