MRgFUS for Parkinson's Tremor

Recruiting now · Not applicable

Conditions studied: Parkinson s Disease, Tremor

In brief

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.

Key facts

Study ID

NCT07284719

Run by

Aarhus University Hospital

People needed

20

Starts

2025-12-01

Expected to finish

2029-02-01

Last updated by the study team

2026-01-07

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aarhus University Hospital — Aarhus, Denmark (enrolling)

Full record on ClinicalTrials.gov

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