RecruitingNot ApplicableNCT07284719

MRgFUS for Parkinson's Tremor

Predictors and Mechanisms of Tremor Relapse After MR-Guided Focused Ultrasound Thalamotomy in Parkinson's Disease

Sponsor

Aarhus University Hospital

Enrollment

20 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Tremor Parkinson's Disease

Summary

This study investigates magnetic resonance-guided focused ultrasound thalamotomy (MRgFUSth) for people with Parkinson's disease (PD) and tremor not responding to conventional standard doses of dopamine replacement therapy. The aim is to identify clinical and imaging biomarkers predictive of sustained tremor control up to 24 months after MRgFUSth treatment. Participants will undergo a suprathreshold levodopa test and ¹⁸F-DOPA PET imaging to evaluate dopaminergic and serotonergic involvement in tremor. All participants will receive MRgFUSth and be followed for 24 months with standardized clinical, cognitive, and quality-of-life assessments. The study seeks to improve understanding the possible mechanisms of tremor relapse and inform patient selection for MRgFUSth in PD.

Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a non-invasive brain procedure called MRI-guided focused ultrasound (MRgFUS) to reduce tremors in people with Parkinson's disease whose shaking has not improved with medication. **You may be eligible if...** - You have been diagnosed with Parkinson's disease - Your tremors cannot be controlled with medication - Your doctor has recommended MRgFUS treatment - You are able to understand the study and give consent - Your Parkinson's is in a mild to moderate stage (Hoehn and Yahr scale below 3) **You may NOT be eligible if...** - You have dementia or serious memory/thinking problems - You have another major brain or psychiatric condition - You have severe balance or walking problems - You have epilepsy or a history of stroke - You are currently misusing drugs or alcohol - You have a pacemaker or cannot have an MRI - You are pregnant or breastfeeding - You are claustrophobic or cannot lie still for 2–4 hours 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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