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MRgFUS for Parkinson's Tremor

RecruitingNAAges 50 Years - 80 YearsAllAarhus University Hospital
NCT07284719 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Established diagnosis of idiopathic Parkinson's disease * Tremor not manageable with optimal medication * Clinical Indication for MRgFUSth * Able to understand study requirements and provide consent * HOEHN and YAHR \<3 Exclusion Criteria: * Dementia or severe cognitive impairment * The presence of another significant neurological/psychiatric disorder or significant disease * Severe psychopathology, not medically managed * Poor balance and gait function based on neurological examination * Epilepsy * Active drug abuse * History of stroke or structural lesions on MRI that could interfere with image analysis. * Contraindications for MRI * Cardiac pacemaker * Pregnancy or breast-feeding * Claustrophobia * Patients unable to lie on the back for 2-4 hours in the MR-scanner-setting * Patients who do not want information about findings of unknown disease during the trial * SDR (Skull density rate) lower than 0.35
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What it tests

  • MR-guided focused ultrasound thalamotomy
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Where

1 site
Aarhus University Hospital
Aarhus, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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