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

NCT03319485 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-03-20

No results posted yet for this 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

  • Parkinson Disease

Interventions

DEVICE

ExAblate Pallidotomy

ExAblate Pallidotomy for Parkinson's Disease

DEVICE

Sham ExAblate Pallidotomy

ExAblate MRgFUS Sham Procedure

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2024-07-25
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Israel
  • Italy
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03319485 on ClinicalTrials.gov