RecruitingNot ApplicableNCT06584383

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

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


Sponsor

InSightec

Enrollment

72 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a focused ultrasound procedure — which uses sound waves to precisely target a small area deep in the brain without surgery — can safely reduce the motor symptoms of early-stage Parkinson's disease on one side of the body. **You may be eligible if...** - You are between 30 and 65 years old - You have been diagnosed with Parkinson's disease for less than 5 years (but more than 12 months) - Your Parkinson's symptoms are primarily movement-related (tremor, stiffness, or slowness) and mainly affect one side of your body - You have tried Parkinson's medications but still have significant motor symptoms **You may NOT be eligible if...** - You have had Parkinson's symptoms for more than 5 years - You have had prior brain surgery - You have a pacemaker, metal implants in the head, or cannot undergo MRI - You have severe dementia or significant psychiatric conditions - You have uncontrolled high blood pressure or serious heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREExablate MRgFUS subthalamotomy

Exablate MRgFUS subthalamotomy for Parkinson's Disease

DRUGBest Medical Treatment

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


Locations(4)

Pontificia Universidad Catolica de Chile

Santiago, Chile

Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)

Kiel, Germany

HM CINAC- Hospital Universitario HM Puerta del Sur

Móstoles, Spain

Clinica Universidad de Navarra

Pamplona, Spain

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NCT06584383


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