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A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease

NCT06584383 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-05-06

No results posted yet for this study

Summary

This prospective, randomized, multicenter study aims to evaluate in Early-Stage Parkinson's Disease (ESPD) patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment.

Conditions

  • Parkinson Disease

Interventions

PROCEDURE

Exablate MRgFUS subthalamotomy

Exablate MRgFUS subthalamotomy for Parkinson's Disease

DRUG

Best Medical Treatment

Subjects will be managed according to conventional therapeutic guidelines (i.e., best medical treatment) for Parkinson's Disease

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • José Obeso, MD, PhD · HM CINAC- Hospital Universitario HM Puerta del Sur

  • Raúl Martínez-Fernández, MD, PhD · HM CINAC- Hospital Universitario HM Puerta del Sur

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2027-09-30
Completion
2029-09-30

Countries

  • Chile
  • Germany
  • Spain

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 NCT06584383 on ClinicalTrials.gov