Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

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

NCT03319485 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DEVICE ExAblate Pallidotomy
  • DEVICE Sham ExAblate Pallidotomy

Study Locations (20)

Other

  • 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
  • Chang Bing Show Chwan Memorial Hospital — Changhua
  • St. Mary's Hospital — London

New York

  • New York University Health Langone — New York
  • Weill Cornell Medicine — New York

California

  • Stanford University Medical Center — Stanford

Florida

  • Palm Beach Neuroscience Institute/Sperling Medical Group — Boynton Beach

Maryland

  • University of Maryland Medical System — Baltimore

Massachusetts

  • Brigham and Women's Hospital — Boston

Minnesota

  • Mayo Clinic — Rochester

Ohio

  • The Ohio State Wexner Medical Center — Columbus

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2018-02-09
Est. Completion 2026-08-31
Phase NA

Sponsor

InSightec

76 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03319485

The ClinicalTrials.gov registry entry for NCT03319485 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InSightec, which has 76 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions — of which ExAblate Pallidotomy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03319485 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03319485 about?

NCT03319485 is a clinical study titled "ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease". 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.

What is the current status of trial NCT03319485?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 92 participants. The study started on 2018-02-09. Estimated completion is 2026-08-31.

What conditions does trial NCT03319485 study?

This clinical trial studies the following conditions: Parkinson Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03319485?

The interventions under investigation include: ExAblate Pallidotomy (DEVICE), Sham ExAblate Pallidotomy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03319485?

This trial is sponsored by InSightec, which has 76 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03319485 being conducted?

This trial has 20 study locations across California, Florida, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial